Prophylactic metoclopramide use in trauma patients given tramadol: A randomised, double-blinded, placebo-controlled trial

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1 789586HKJ / Hong Kong Journal of Emergency MedicineChoo et al. research-article2018 Original Article Prophylactic metoclopramide use in trauma patients given tramadol: A randomised, double-blinded, placebo-controlled trial Hong Kong Journal of Emergency Medicine 2019, Vol. 26(2) The Author(s) 2018 Article reuse guidelines: sagepub.com/journals-permissions DOI: journals.sagepub.com/home/hkj Kim Hoon Choo 1, Rishya A/L Manikam 2, Khadijah Poh Yuen Yoong 2 and Vanitha A/P Kandasamy 1 Abstract Background: Tramadol is a common analgesia used in Emergency Department for trauma patients. However, it causes multiple side effects, most notably nausea and vomiting. Objectives: The aim of this study is to determine whether routine administration of prophylactic metoclopramide in patients receiving intravenous tramadol for injuries of extremities is beneficial. Method: A randomised, double-blinded, placebo-controlled trial was carried out on 200 trauma patients requiring tramadol for acute pain in Emergency & Trauma Department of Sarawak General Hospital. Patients were randomised into two groups, group one received metoclopramide 10 mg intravenously while group two received placebo. Nausea severity (measured on a visual analogue scale) before and after tramadol administration, number of episodes of vomiting and patients demographic data were recorded. Results: A total of 191 patients were recruited, in which the metoclopramide group had 96 patients while the placebo group had 95 patients. In total, 5 out of 191 patients had significant worsening of nausea severity and all were from the placebo group (5.26%). The difference was statistically significant (p = 0.029, Fisher s exact test). Only 1 out of 191 patients vomited and was from the placebo group. No adverse reaction was reported in both groups of patients. Conclusion: Routine administration of intravenous metoclopramide may be beneficial in musculoskeletal trauma patients receiving tramadol. Keywords Antiemetic, metoclopramide, tramadol, trauma, nausea, vomiting Introduction Pain is one of the most common presenting complaints in emergency departments (EDs). 1 Acute pain relief is an important aspect in emergency care, alleviating not only patients discomfort but also interrupting the pain cycle which releases stress hormones. Trauma is one of the common causes of acute pain, and opioids are commonly used as primary analgesics in emergency setting. However, opioids come with adverse effects, most notably gastrointestinal effects of nausea, vomiting and constipation, central nervous effects such as sedation, and cardio-respiratory depression. Many strategies have been postulated to minimise opioid-induced adverse effects. 2 Opioid-induced nausea and vomiting are one of the common side effects. It has been presumed that routine administration of prophylactic antiemetic is beneficial in patients receiving opioids in order to prevent opioid-induced nausea 1 Emergency & Trauma Department, Sarawak General Hospital, Kuching, Malaysia 2 Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia Corresponding author: Kim Hoon Choo, Emergency & Trauma Department, Sarawak General Hospital, Kuching, Malaysia. kimhoonchoo@gmail.com Creative Commons Non Commercial CC BY-NC: This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License ( which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (

2 Choo et al. 99 and vomiting. 3 According to one Australian study, 23% of ED patients were given prophylactic metoclopramide after opioid administration. However, the efficacy of prophylactic metoclopramide was poorly established, causing further doubt in routine prophylactic metoclopramide. 4 Some literature reviews mentioned that prophylactic antiemetics generally are not necessary before administration of opioid. 2 This study aims to determine if there is benefit in routine administration of an antiemetic (metoclopramide) to patients receiving intravenous (IV) opioid (tramadol) for injuries of extremities. Research methodology Study design and setting This study was a randomised, double-blinded, placebocontrolled trial conducted in the Emergency & Trauma Department (ETD) of Sarawak General Hospital. The conduct of the study was approved by the Medical Research and Ethics Committee (MREC) Malaysia and was registered with the National Medical Research Register (NMRR ). The trial ran over approximately 6 months. We calculated that 180 patients would need to be recruited to give this study 80% power at 5% significance level. This was based on assumption that 20% of patients receiving tramadol would have worsening nausea or vomited, as literature review showed that incidence of nausea and vomiting for patients treated with therapeutic doses of opioids were 8% 40% and 15% 40%, respectively. 5 Selection of participants Patients presenting to ETD of Sarawak General Hospital with traumatic injuries of extremities requiring tramadol for pain relief were recruited. Patients were not recruited consecutively. They were recruited at unplanned intervals during the study period, subject to availability of the investigator and patient consent. Informed consent was obtained from all participating patients (Appendix 1). Patients were eligible for this study if they were aged 18 years or older and sustained from acute injuries of extremities during their presentation to ETD. Patients were excluded should they have any of the following: Known allergy to metoclopramide; Injuries to other organ systems (brain, chest, abdomen and pelvis); Concurrently taking medication with antiemetic effect, including antihistamines, phenothiazines and dopamine antagonists; A history of vomiting since time of injury; Patients who have received tramadol or metoclopramide 8 h prior to arrival at ETD; Below age of 18 years on day of presentation or patients who could not give consent to the study; Any alteration in level of consciousness; Hemodynamic instability or primary diagnosis requiring time critical intervention; Pregnancy or lactation; History or known case of vertiginous disorder; Currently undergoing chemotherapy or radiotherapy. If there were no exclusion criteria, written informed consent was obtained and baseline information, including details of the injuries sustained, was recorded. All patients recruited were given IV tramadol 50 mg. If pain relief was not achieved during the study period of 1 h, patients were given additional doses of tramadol to a maximum of total dose of 100 mg. Patients who required further doses of tramadol beyond 100 mg or other analgesic agents within the study period were withdrawn from the study. This is to avoid unnecessarily increased incidence of nausea and vomiting due to tramadol overdose as the recommended dose of IV tramadol by British National Formulary is mg and also side effects from other types of analgesics. Interventions The study drugs were prepared under sterile conditions by a pharmacist independent to the study and kept in packs. Each study pack contained two 3-mL syringes, each containing identically appearing clear fluid. These were either (1) one 3-mL syringe containing 1 ml of tramadol 50 mg and one 3-mL syringe containing 2 ml of metoclopramide 10 mg or (2) one 3-mL syringe containing 1 ml of tramadol 50 mg and one 3-mL syringe containing 2 ml of sodium chloride 0.9%. The patients recruited were randomised to receive one of the study packs. A computergenerated random number sequence would be used to assign treatment allocations and numbering of the study packs. The allocation list was kept by the pharmacist, who could be contacted in the event of serious adverse event. The pharmacist monitored the pack numbers and prepared the study packs in batches of four. All study packs were stored in ETD drug refrigerator and kept for a maximum of 24 h. After enrolment and recording of baseline information, the medication in the study pack was administered. Tramadol was administered over 2 3 min, as per British National Formulary. Treatment for patients presenting illness was performed at the same time. All patients recruited were then followed up until 60 min. Nausea severity ratings before and 60 min after administration of medication, number of episodes of vomiting and any other adverse events were obtained. The need for use of antiemetic rescue medication (IV ondansetron 4 mg) was determined on discussion between patient and the physician.

3 100 Hong Kong Journal of Emergency Medicine 26(2) To maintain blinding, treatment allocations were revealed only after study completion, when all outcome measurements had been performed and recorded by the investigator in the study database. The treatment packs were unblinded prior to statistical analysis. Methods of measurement Nausea severity was rated on a visual analogue scale (VAS) on enrolment (before administration of study drugs) and 60 min after administration of the study drugs. VAS is a standard 100 mm line marked no nausea at the left end and worst nausea imaginable at the right end. Use of VAS for measurement of nausea severity and change has been validated, and the minimum clinically significant difference defined for this study is 20 mm. 6 Number of vomiting episodes during the 60-min study period was self-reported by the patient. Outcome measures The primary outcome was mean change in severity rating on the VAS 60 min after administration of the study drugs. Secondary outcomes were number of vomiting episodes, need for rescue medication and adverse events. Data entry and analysis The data were recorded into several variables as below: Demographic variables: age, gender, marital status, race, level of education and co-morbid(s); Data peculiar to the injury sustained: date and time of presentation to ETD, date and time of injury, type of injuries (fracture, laceration wound or soft tissue injury) and site of injury; Randomisation information: date of randomisation, time of administration of medication in study pack, additional dose of tramadol if needed for further pain relief during the study period; Outcome information: VAS of nausea severity in mm at 0 min (before administration of study pack) and 60 min after administration of study pack, number of episodes of vomiting during the 1-h study period, use of rescue medication (IV ondansetron 4 mg), other adverse reactions from medication given. Data were then entered and analysed using Statistical Package for Social Science (SPSS) for Windows, version Baseline data are presented as mean, number and percentage. For the primary outcome, change in rating is reported as mean. Comparison of mean change between groups uses independent t-test. Significant increment of nausea severity on VAS (20 mm or more) is compared between groups with either Chi-square test or Fisher s exact test, whichever appropriate. Results A total of 200 patients were recruited over the study period of 6 months, of which 191 of them were randomised (Figure 1). Analysis at the end of the study showed that 96 patients received metoclopramide and 95 patients received placebo (normal saline). Characteristics of the patients were demonstrated in Table 1. The two groups were evenly matched for type of injury, gender, age and race (Table 1). Severity of nausea was measured using VAS before administrating the treatment pack, which contained tramadol 50 mg and either metoclopramide 10 mg or placebo, and 1 h after administration of medication. Additional dose of tramadol could be given during the study period to a maximum total dose of 100 mg. There was a mild drop in the mean VAS score in patients who were given metoclopramide, while in patients who were given placebo there was an increase in the mean VAS score of nausea severity (Table 2), and the difference was significant (p = 0.003). During the 1-h study period, 5 patients out of 191 (2.62%) had significant worsening of nausea, as measured by increment of more than 20 mm on VAS. All 5 patients were in the group receiving placebo (5/95, 5.26%), making the difference significant (p = 0.029, Fisher s exact test), as shown in Table 3. Only 1 patient out of 191 (0.52%) vomited, and was in the group receiving placebo. One patient in the metoclopramide group received additional 50 mg of tramadol, and did not have significant worsening of nausea and vomiting. None of the patients in the placebo group received additional dose of tramadol. None of the patient required rescue medication (IV ondansetron 4 mg) for the relief of severe nausea and vomiting. There were no other adverse effects noted in any of the study patients. Measurement bias was minimised because of patients self-reporting of outcomes, and the use of VAS as a measure in this setting has been validated. Discussion Pain relief is one of the priorities of emergency medicine. In our centre, tramadol has been the IV opioid of choice for analgesic in trauma patients. All opioids have side effects, including tramadol. 7 The most common side effects caused by opioids are nausea and vomiting. Prophylactic antiemetics have been used together with opioids to counter their emetic side effects. In the United Kingdom, prophylactic antiemetic is routinely administered to all patients receiving opioids. 1 Reports showed that incidence of nausea and vomiting for patients treated with therapeutic doses of opioids were 8% 40% and 15% 40%, respectively. 5,8 These studies included medical and surgical patients as well as patients who were on regular doses of tramadol. When used in post-operative pain management, it was found that tramadol has relatively high incidence of nausea and vomiting, with up to 20% of patients complained of nausea. 9 Opioids induce nausea and vomiting through multiple mechanisms.

4 Choo et al. 101 Figure 1. Study flowchart. Table 1. Baseline characteristics of the patients in the two study groups. Variable Group Difference Metoclopramide (n = 96) Normal saline (n = 95) Type of injury (%) Fracture 54 (56.3%) 60 (63.2%) Laceration wound 7 (7.3%) 13 (13.7%) Soft tissue injury 35 (36.5%) 22 (23.2%) p = Gender (%) Male 70 (72.9%) 75 (78.9%) Female 26 (27.1%) 20 (21.1%) p = Mean age (years) 40 (18 86) 38 (18 89) p = Race (%) Malay 37 (38.5%) 41 (43.2%) Chinese 20 (20.8%) 18 (18.9%) Iban 20 (20.8%) 17 (17.9%) Bidayuh 16 (16.7%) 16 (16.8%) Others 3 (3.1%) 3 (3.2%) p = These may include direct stimulation of chemoreceptor trigger zone (CTZ), decreased gastrointestinal motility and increased vestibular sensitivity. 10 Multiple antiemetics have been used to treat opioid-induced emesis, including antipsychotics, dopamine receptor antagonists, serotonin antagonists, antihistamines and corticosteroids. 11 According to a review by Canadian Agency for Drugs and Technologies in Health in 2014, there is no proven clinical benefit of one antiemetic over another in treating opioid-induced nausea and vomiting. 12

5 102 Hong Kong Journal of Emergency Medicine 26(2) Table 2. Comparison of mean change in nausea severity score between groups. N VAS of nausea severity at 0 min Mean (SD) VAS of nausea severity at 60 min Mean (SD) Difference 95% confidence interval p-value Metoclopramide (7.43) 1.72 (4.75) , Normal saline (8.96) 6.63 (11.91) 3.16 VAS: visual analogue scale; SD: standard deviation. Table 3. Increment of nausea severity visual analogue scale of more than 20 in the study groups. Group VAS increment 20 or more Total p-value Yes No Metoclopramide Normal saline VAS: visual analogue scale. D2 (dopamine receptor subtype 2), 5-HT3 (serotonin type 3) and NK1 (neurokinin 1) neuroreceptors can be found in the CTZ. Dopamine receptor antagonists work in this neural pathway to treat opioid-induced nausea and vomiting. 13 Metoclopramide is a dopamine (D2) receptor antagonist with short half-life and mixed 5-HT3 receptor antagonist and 5-HT4 (serotonin type 4) receptor agonist. In addition to its antidopaminergic action, metoclopramide has a prokinetic activity on the upper digestive tract. Its combined action on CTZ and intestinal motility contribute to its powerful antiemetic effect. However, like most dopamine antagonists, metoclopramide has no selectivity for the dopamine receptors in the CTZ; therefore, it may cause hyperprolactinaemia and extrapyramidal motor disturbance, by acting on dopaminergic systems in other parts of the brain. 14 Therefore, use of metoclopramide is not without risk. Up to 20% of patients who are given therapeutic dose of metoclopramide experience side effects, most notably drowsiness and lassitude 15 and approximately 1% of patients experience true dystonic reaction. 16 Its usage has therefore been restricted by European Medicines Agency. 17 There is currently no evidence in the literature to show that nausea and vomiting caused by tramadol administration can be significantly reduced or prevented by prophylactic antiemetic. We have come across similar studies in the literature, but those studies involved morphine instead of tramadol. In this study, we intended to limit recruitment to patients who sustained traumatic injury of the extremities in order to minimise other factors which also result in nausea and vomiting. This is a prospective, randomised, doubleblinded, placebo-controlled study. The randomisation process involved the supply of prefilled, numbered syringes containing either metoclopramide or normal saline. These syringes were prepared by an independent pharmacist. After administration of the medications, the patient was observed for 1 h and nausea severity and number of episode of vomiting were recorded. Our study showed that the incidence of nausea and vomiting is low (2.62% and 0.52%, respectively) when tramadol is used in treating acute pain in patients with traumatic limb injuries. However, all of those who experienced nausea and vomiting were from the placebo group. There was statistically significant difference between the two groups in severity of nausea, as measured by increment of 20 mm on VAS. However, none of the patients required rescue medication, ondansetron, which is a serotonin 5-HT3 receptor antagonist. This study was designed to determine if there was benefit in the routine administration of an antiemetic to patients receiving IV tramadol in the ED. The group selected was confined to trauma of the extremities. The study suggested that prophylactic antiemetic may be beneficial. Although the incidence of nausea and vomiting was low in patients receiving tramadol, statistically there was significant difference in the nausea severity ratings. Target dose is a key determinant in tramadol tolerability. The rate of adverse reactions may differ depending on different dosages of tramadol. Gana et al. conducted a study to determine the relationship between tramadol dose and discontinuation rate due to adverse reactions. It demonstrated that the discontinuation rate was significantly higher in subjects receiving higher dose of tramadol. 18 Another study also showed higher dose of tramadol (2 mg/ kg) was associated with higher rate of adverse effects, despite having better analgesic effect. The rate of side effects was as high as 66.1% when higher dose of tramadol was administered. 19 Further studies may be carried out to determine the role of prophylactic antiemetic with different dosages of tramadol. Besides, in this study, sample size recruited was based on the assumption of 20% of patients having worsening nausea after IV tramadol administration. This calculation was based on previous literature review. In this study, the incidence of nausea was much lower. Therefore, future study with higher number of sample size based on lower incidence of tramadol-induced nausea and vomiting is needed to confirm the findings. In addition, the results of this study are only applicable to IV tramadol and cannot be applied to other routes of delivery (e.g. intramuscular administration) and other types of opioid as different opioids have varying emetic potential.

6 Choo et al. 103 Conclusion Prophylactic antiemetic metoclopramide may be beneficial in reducing severity of nausea due to IV tramadol administration. However, the incidence of tramadol-induced vomiting is low, only one patient vomited in this trial. Therefore, evaluation of prophylactic metoclopramide in larger trials of patients seems warranted. Further study may include patients who present with other illnesses besides trauma and also include different routes of tramadol administration. Acknowledgements The authors want to acknowledge and thank all the supervisors, Associate Prof Dr R.A.L.M., Dr K.P.Y.Y. and Dr V.A.P.K. for their time and effort spent on guiding me to complete this research. The authors express foremost gratitude to Dr Mohamad Adam Bujang, statistician of Clinical Research Centre of Sarawak General Hospital, and Miss Mary Chen Siew Ying, pharmacist of Emergency & Trauma Department of Sarawak General Hospital, for helping. Declaration of conflicting interests The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Conflict of interest was declared under Medical Research and Ethics Committee (MREC) Malaysia on 25 September Funding The author(s) received no financial support for the research, authorship and/or publication of this article. Availability of data and materials All the data and patient information will be kept private. All study data and personal information will be kept for 5 years at Emergency & Trauma Department Record Office of Sarawak General Hospital after the study is completed and will be destroyed after the period of storage. Ethical approval Ethical approval was obtained from the Medical Research and Ethics Committee (MREC) Malaysia and was registered with the National Medical Research Register (NMRR ). Human rights Patients can always withdraw from the study at any time during the study period. All the emergency care will be given even if they are not part of the study anymore. If patients are injured as a result of being in this study, they can contact the study doctor. In the event of a bodily injury or illness directly resulting from the study product, reasonable and necessary treatment will be paid for. References 1. Bradshaw M and Sen A. Use of a prophylactic antiemetic with morphine in acute pain: randomised controlled trial. Emerg Med J 2006; 23(3): Swegle JM and Logemann C. Management of common opioid-induced adverse effects. Am Fam Physician 2006; 74(8): Lambie B, Chambers J and Herbison P. The role of prophylactic anti-emetic therapy in emergency department patients receiving intravenous morphine for musculoskeletal trauma. Emerg Med Australas 1999; 11(4): Simpson PM, Bendall JC and Middleton PM. Review article: Prophylactic metoclopramide for patients receiving intravenous morphine in the emergency setting: a systematic review and meta-analysis of randomized controlled trials. Emerg Med Australas 2011; 23(4): Aparasu R, McCoy RA, Weber C, et al. Opioid-induced emesis among hospitalized nonsurgical patients: effect on pain and quality of life. J Pain Symptom Manage 1999; 18(4): Meek R, Kelly AM and Hu XF. Use of the visual analog scale to rate and monitor severity of nausea in the emergency department. Acad Emerg Med 2009; 16(12): Campora E, Merlini L, Pace M, et al. The incidence of narcotic-induced emesis. J Pain Symptom Manage 1991; 6(7): Langley PC, Patkar AD, Boswell KA, et al. Adverse event profile of tramadol in recent clinical studies of chronic osteoarthritis pain. Curr Med Res Opin 2010; 26(1): Radbruch L, Grond S and Lehmann KA. A risk-benefit assessment of tramadol in the management of pain. Drug Saf 1996; 15(1): Smith HS, Smith JM and Seidner P. Opioid-induced nausea and vomiting. Ann Palliat Med 2012; 1(2): Cherny N, Ripamonti C, Pereira J, et al. Strategies to manage the adverse effects of oral morphine: an evidence-based report. J Clin Oncol 2001; 19(9): CRR Reports. Antiemetics for adults experiencing opioidinduced nausea: a review of clinical and cost-effectiveness, benefits and harms, and guidelines. Ottawa, ON: CADTH Rapid Response Reports, Smith HS, Cox LR and Smith BR. Dopamine receptor antagonists. Ann Palliat Med 2012; 1(2): Coluzzi F, Rocco A, Mandatori I, et al. Non-analgesic effects of opioids: opioid-induced nausea and vomiting: mechanisms and strategies for their limitation. Curr Pharm Des 2012; 18(37): Albibi R and McCallum RW. Metoclopramide: pharmacology and clinical application. Ann Intern Med 1983; 98(1): Desmond PV and Watson KJ. Metoclopramide a review. Med J Aust 1986; 144(7): Valkova M, Stamenov B, Peychinska D, et al. Metoclopramide induced extrapyramidal signs and symptoms brief review of literature and case report. J of IMAB 2014; 20(6): Gana TJ, Pascual ML, Fleming RR, et al. Extended-release tramadol in the treatment of osteoarthritis: a multicenter, randomized, double-blind, placebo-controlled clinical trial. Curr Med Res Opin 2006; 22(7): Hassanian-Moghaddam H, Rashidi B and editors. Mortality and complication associated with acute tramadol intoxication. Clin Toxicol 2008; 46: 362.

7 104 Hong Kong Journal of Emergency Medicine 26(2) Appendix 1 Consent form for patient Title of Research: Prophylactic metoclopramide use in trauma patients given tramadol: A randomised, doubleblinded, placebo-controlled trial Name of patient: IC number: Randomisation number: 1. I confirm that I have read and understood the information sheet for the above study and have had the opportunity to ask questions. 2. I understand that my consent is voluntary and that I am free to withdraw this consent at any time, without giving any reason and without my medical care or any legal rights being affected. 3. I understood that sections of my medical notes may be looked at by responsible individuals involved in the study. I give permission for these individuals to have access to these records. 4. I agree to take part in the above study. Patient: Name of Patient IC number Date Signature/ Thumbprint Investigator conducting informed consent: Name of IC number Date Signature investigator Information for patients Title of Research: Prophylactic metoclopramide use in trauma patients given tramadol: A randomised, doubleblinded, placebo-controlled trial After your injury, you will get all the usual emergency care that we provide at this hospital. You will be explained about the research and then make decision whether to participate in the study. The participation is voluntary. Before you decide, it is important that you know why the study is being done and what it involves. Please read the information below and ask as many questions as you like before deciding. The doctor will be happy to talk to you about the study and answer any questions. 1. What is the purpose of this study? The aim of this study is to determine whether metoclopramide is needed in preventing the main side effects of tramadol, which are nausea and vomiting. 2. What does taking part in this study involve? All the usual emergency treatments will be given. We do not know whether metoclopramide will help to prevent nausea and vomiting when the patients are given tramadol as painkiller, so half the patients in the study will get metoclopramide and the other half will get a placebo (dummy treatment). The choice of what to give (metoclopramide or placebo) is made randomly, and you will have an equal chance of receiving either one. The doctors looking after you do not know whether you received metoclopramide or placebo. You will not need to undergo any extra tests or spend any extra time in hospital as a result of taking part in this study. The study treatment is free. The study products do not contain porcine and bovine components: Group 1: Intravenous tramadol 50 mg + intravenous metoclopramide 10 mg; Group 2: Intravenous tramadol 50 mg + placebo (intravenous sodium chloride 0.9%). The placebo looks like the study treatment but has no active medication. Total patients involved in this study will be 180, with 90 in each arm. The study period will be 1 h, starting when the patient is given the study medications. The patient will be further monitored for another 3 h to ensure the safety of the patient. 3. What are the possible risks of being in the study? Both tramadol and metoclopramide are not new drugs. Tramadol has been used for years as analgesic to treat acute pain. There are no serious side effects with short term use. Minor side effects include nausea, vomiting and dizziness. Metoclopramide has been used as an antiemetic (treatment to stop nausea and vomiting). However, it is not known whether it has a role as a prophylaxis in preventing incidence of nausea and vomiting in patients given tramadol. Minor side effects of metoclopramide are rare and not serious, but may include headache, dizziness and sedation. 4. What are the possible benefits of being in the study? There may or may not be any benefits to you. However, the knowledge that we gain from this study will help people in the future. 5. What if I don t want to be a part of this study anymore? You can always withdraw from the study at any time. All the usual emergency care will be given to you even if you are not part of the study anymore.

8 Choo et al Will the information you collect be kept private? All information about you and the injury will be kept private. The only people allowed to look at the information will be the doctor running the study and the regulatory authorities who check that the study is being carried out correctly. Personal information will be used in strict confidence and will not be released under any circumstance. We will publish the results of the study in a medical journal so that other doctors can benefit from the knowledge, but your personal information will not be included and there will be no way that you can be identified. 7. Who can you contact about any questions or problems? If you have any questions or concerns about any aspect of this study, you should ask to speak with the study doctors who will do their best to answer your questions. Dr Kim Hoon Choo is in charge of this study. You can contact the doctor at: Address: Sarawak General Hospital, Department of Emergency & Trauma, Jalan Tun Ahmad Zaidi Adruce, Kuching, Sarawak Telephone: If you are still unhappy and wish to complain formally, you can do this through the hospital s complaints procedure. Please ask the researcher for details. If you have any questions about your rights as a participant in this study, please contact The Secretary, Medical Research & Ethics Committee, Ministry of Health Malaysia, at telephone number Who has reviewed the study? To protect your interests, all studies conducted at this hospital are looked at by an independent group of people called Research Ethics Committee. This study has been reviewed and has been given a favourable ethical opinion by the Medical Research & Ethics Committee, Ministry of Health, Malaysia. 9. What happens afterward? We would like to hear if you develop any medical problems after discharge from this hospital and at any time up to 28 days. You will be given a card with the contact details of the research doctor at this hospital, which should be kept in a safe place and presented to anyone who may be treating you for any illness. All study data and personal information will be kept for 5 years at Emergency & Trauma Department Record Office of Sarawak General Hospital after the study is completed and will be destroyed after the period of storage. If you would like to have a copy of the final results of this study, please let the research doctor know and he or she will ensure you receive a copy when the results are published. 10. What else do you need to know? Indemnity. If you are injured as a result of being in this study, you should contact the study doctor. In the event of a bodily injury or illness directly resulting from the study product, reasonable and necessary treatment will be paid for. You do not lose any of your legal rights to seek compensation by signing this form. We will ask you to sign a separate consent form and give you a copy to keep and you can also keep this information sheet.