Management of post-strabismus nausea and vomiting in children using ondansetron: a value-based comparison of outcomes 1^

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1 British Journal of Anaesthesia 89 (3): (2002) Management of post-strabismus nausea and vomiting in children using ondansetron: a value-based comparison of outcomes 1^ B. Sennaraj 1, D. Shende 1, S. Sadhasivam 2 *, S. Ilavajady 3 and D. Jagan 1 All India Institute of Medical Sciences, New Delhi, India. Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA. Northern General Hospital, Sheffield Teaching Hospital NHS Trust, Sheffield, UK. ^Corresponding author: Department of Anesthesia, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Harvard Medical School, Boston, MA 02115, USA Background. This study evaluated the clinical efficacy and cost-effectiveness of prophylactic ondansetron versus early ondansetron treatment in the management of postoperative nausea and vomiting (PONV) in children undergoing strabismus repair using clinically meaningful outcomes and value-based principles. Methods. One hundred and fifty children were randomly assigned to either prophylactic (P) or early symptomatic treatment only (T) group (n=75). Children in group P received ondansetron 100 fig kg" 1 i.v. and those in group T received placebo at the end of the procedure. After surgery, at the earliest sign of nausea or vomiting, children in both groups received ondansetron 100 (ig kg" 1 i.v. Besides the incidence of PONV, non-surrogate (fast tracking time, duration of stay in the postanaesthesia care unit (PACU) and parental satisfaction scores), therapeutic (numbers needed to prevent and treat) and pharmacoeconomic (cost to benefit a child and cost per PONV-free child) outcome measures were evaluated. Results. The incidences of PONV in the immediate, early, late and first 24-h periods were significantly less in group P (20, 12, 19 and 35% respectively) than in group T (37, 29, 47 and 72%, P<0.05). Time to achieve fast-track eligibility and duration of PACU stay were significantly shorter in group P (P<0.00l). Children in group P had superior mean (SD) parental satisfaction scores (8.2 (1.8)) compared with those in group T (6.8 (1.7), P<0.001). The number needed to prevent PONV was 2 and the number needed to treat PONV was 9. The cost to benefit a child was more than fourfold less and the cost per PONV-free child was 35% less in group P. Conclusions. Compared with early symptomatic treatment with ondansetron, prophylactic ondansetron shortened fast-tracking time and duration of PACU stay and improved parental satisfaction and therapeutic outcomes at a lower direct cost. BrJ Anaesth 2002; 89: Keywords: vomiting, postoperative nausea and vomiting; vomiting, antiemetics, ondansetron; anaesthesia, audit Accepted for publication: March 6, 2002 Controversy in the management of postoperative nausea and ondansetron. However, in adult patients undergoing outvomiting (PONV) continues despite the availability of patient surgery, prophylaxis with ondansetron had been effective and newly developed antiemetics. This is mainly shown not to improve outcomes when compared with early because of the multifactorial aetiology of PONV, different symptomatic treatment. 4 There is no clinical evidence to risks of PONV in different patient populations, different recommend the use of prophylactic ondansetron rather than antiemetic approaches and different desired outcomes. A recent clinical trial 1 in children undergoing strabismus repair which evaluated clinically more important non- + T his work was supported by institutional and departmental sources. surrogate and therapeutic outcome measures recom- The study was presented at the annual meeting of American Society of mended the practice of prophylactic administration of Anesthesiologists. The Board of Management and Trustees of the British Journal of Anaesthesia 2002

2 Sennaraj et al. treating patients early at the first episode of PONV in a homogeneous high-risk population. This trial evaluated the effectiveness of prophylactic ondansetron versus early treatment of PONV with ondansetron in children undergoing strabismus repair, a population with a high risk of PONV. Fast track eligibility time, duration of stay in the postanaesthesia care unit (PACU), parental satisfaction and therapeutic and pharmacoeconomic outcome measures were also compared. Methods After obtaining institutional review board approval and informed parental consent, in this prospective, randomized, double-blind study, we enrolled and studied 150 children (ASA I or II, aged 2-15 yr) undergoing strabismus repair under general anaesthesia. We excluded children who received drugs known to have antiemetic effects (e.g. phenothiazines, benzamides, scopolamine, corticosteroids, tricyclic antidepressants) in the 24 h before surgery. Children did not consume milk or solid food for at least 6 h before operation; clear fluids were allowed until 3 h before induction. Children were not premedicated. Anaesthesia was induced with halothane and nitrous oxide in oxygen via a facemask or with i.v. thiopental. After induction of anaesthesia and establishment of venous access, tracheal intubation was facilitated with vecuronium 100 \ig kg" 1 i.v., and anaesthesia was maintained with halothane and 66% nitrous oxide along with meperidine 0.5 mg kg" 1 i.v. A random number generator was used to assign each child prospectively to either the prophylactic (P) or the therapeutic (T) group (n=75). At the end of the procedure (when the last extraocular muscle was repaired), children in group P received ondansetron 100 ig kg" 1 i.v. (maximum of 4 mg) and children in group T received saline. The study drugs were prepared by an anaesthetist not directly involved in patient care, to a fixed volume of 5 ml to maintain the double-blind nature of the study. Intraoperative i.v. fluid management consisted of administration of lactated Ringer's solution sufficient to correct half of the preoperative fluid deficit in the first hour, followed by maintenance fluids according to body weight. At the end of the procedure, residual neuromuscular blockade was antagonized with neostigmine 50 jag kg" 1 and glycopyrrolate 10 (ig kg" 1 and the trachea was extubated when the child was awake. All children were transported to the PACU, where they stayed for a minimum of 2 h for initial evaluation and management and for assessment of eligibility for fast tracking. One of the study personnel assessed postanaesthetic recovery, using a modified Aldrete's scoring system, 5 and the time to achieve eligibility for fast tracking [6] (fast tracking time, FTT). Time to achieve complete recovery (a modified Aldrete recovery score of 10) was recorded for all children. FTT was calculated as the time from the discontinuation of anaesthesia to the time at which a child had patent airway without support, no PONV and pain, and a modified Aldrete recovery score of 10. The criteria for discharge from the PACU to the ward included stable vital signs, adequate pain control and no nausea and vomiting in the first 2 h after surgery. Children who had PONV and/or pain were observed in the PACU until they had been free of PONV and pain for 1 h. All episodes of PONV in the first 24 h in the hospital were recorded at intervals of 0-2, 2-6 and 6-24 h by the PACU and ward nursing staff, who were aware of the nature of the study but blinded to the study drug. We did not assess nausea in younger children (less than 6 yr of age). In older children, nausea was assessed by an observer asking the child whether he or she had any nausea, in addition to selfreporting. Any child having an episode of vomiting or nausea was treated with ondansetron 100 jig kg" 1 i.v. (maximum 4 mg) as the first postoperative antiemetic. If ondansetron failed to control nausea and vomiting in 30 min, metoclopramide 150 jig kg" 1 and promethazine 0.5 mg kg" 1 were used as the rescue antiemetics (second and third choices respectively). Postoperatively, analgesia was provided when older children complained or younger children cried in pain. 7 Oral ibuprofen 10 mg kg" 1 was administered as the analgesic of first choice and, for pain in children who had PONV, ketorolac 0.5 mg kg" 1 i.v. was administered as the analgesic of second choice. Intravenous fluid consisted of lactated Ringer's solution to replace the fluid deficit plus maintenance fluids in the recovery room. Finally, at the end of 24 h after surgery, the health-care worker who stayed with the child for most of the time was asked to give a global assessment of satisfaction over the entire postoperative experience of the child on the basis of the presence or absence of nausea, vomiting, pain and other adverse events. Parental satisfaction scores were obtained using an 11-point verbal linear numerical scoring system (0=not at all satisfied, 10=fully satisfied). Power analysis before the study showed that 68 children would be required in each group to give an 80% chance ((3=0.2) of detecting a 25% absolute reduction in the incidence of PONV between the groups for a basal PONV incidence of 55% with a type-1 error of 5% (Epi Info, version 6.04b; Center for Disease Control, Atlanta, GA, USA and World Health Organization, Geneva, Switzerland, 1997). Two sample Mests and the Mann-Whitney (7-test were used to compare the age, weight, durations of anaesthesia, recovery and PACU stay, FTT, perioperative fluid and analgesic requirements and parental satisfaction. The incidences of PONV and rescue antiemetic requirements were compared by the % 2 and Fisher's exact tests with Yates' continuity correction wherever appropriate. The positive numbers needed to prevent and treat (NNP and NNT) PONV were calculated as the reciprocals of absolute risk reductions of incidences of PONV from our institute's 474

3 PONV and value-based anaesthesia Table 1 Patient characteristics and clinical data. Gender, ASA status, previous PONV, oculocardiac reflex (OCR) and postoperative analgesic requirements are expressed as the number of children. Other values are expressed as mean (SD or range). No significant differences Prophylactic group («=75) Symptomatic treatment group (B=75) Age (yr) Gender (M/F) Weight (kg) ASA physical status I, II Prior PONV Induction (halothane/thiopental) OCR requiring atropine Intraoperative Fluids (ml kg" 1 ) Meperidine (mg) Number of muscles Duration of anaesthesia (min) Recovery time (min) Postoperative analgesia 6.9 (2-15) 29/ (8.5) 67, 8 12/75 57/18 11/ (3.9) 11.2 (4.1) 12/75 45/75 14/75 4/ (13.0) 10.3 (6.79) 11/75 63/ (2-14) 33/ (9.9) 69, 6 9/75 61/14 8/75 16 (4.5) 10.8 (4.8) 17/75 42/75 10/75 6/ (20.9) 11.9 (6.7) 15/75 57/ basal incidence of 83% ] for children who received ondansetron prophylactically and early symptomatic treatment respectively. Similarly, the number needed to improve satisfaction (NNS) was calculated as the reciprocal of the absolute percentage of unsatisfied parents (parental satisfaction score <7.5). The cost to benefit a child was calculated as the drug (ondansetron) acquisition cost per child multiplied by NNT (treatment) or NNP (prevention). The ondansetron acquisition cost per child was calculated by multiplying its acquisition cost in our institution by the mean weight (kg) of the children in each group. For the pharmacoeconomic analysis, we assumed the institutional acquisition costs of 1 mg of ondansetron, 10 mg of metoclopramide and 25 mg of promethazine as US$4, US$0.29 and US$1.25 respectively. The direct antiemetic cost per PONV-free child was calculated by dividing the total acquisition costs of all antiemetics administered (including ondansetron administered prophylactically in group P) by the number of PONVfree children in each group. Results Age, gender, weight, ASA physical status, children with a history of prior PONV, children who were induced with halothane and thiopental, children who required atropine to manage oculocardiac reflex, duration of procedure, perioperative fluid and analgesic requirements, were similar in the two groups (Table 1). The incidence of PONV and nausea alone over 24 h was significantly lower in the prophylactic ondansetron group than in the therapeutic ondansetron group (7MX001) (Table 2). The incidences of PONV in the immediate (20 vs 37.3%, P=0.03), early (12 vs 29.3%, ^=0.015) and late (18.7 vs 46.7%, P<0.001) postoperative periods were significantly lower in the prophylactic ondansetron group (Table 2). The incidences of nausea alone in the immediate (20.5 vs 53.8%, />=0.0016), early (11.4 vs 43.6%, P=0.0021) and late (20.5 vs 61.5%, P=0.001) postoperative periods were significantly lower in the prophylactic group (Table 2). The requirements for rescue antiemetics in different epochs were significantly less in the prophylactic group (Table 2). The positive NNP PONV was 2 in the prophylactic ondansetron group (NNP=2) and 9 in the early symptomatic treatment group (NNT=9) (Table 3). The requirement for rescue antiemetics to manage PONV in the early and the late postoperative periods was significantly less with prophylaxis than with early symptomatic treatment CP<0.001) (Table 2). The duration of recovery and requirements for postoperative analgesics were comparable in the two groups (Table 1). The FTT in the prophylactic ondansetron group was shorter than that in the therapeutic ondansetron group (21.6 (4.1) vs 28.2 (5.3) min, P). The duration of PACU stay was significantly longer in the therapeutic group than in the prophylactic ondansetron group (141.1 (30.6) vs (13.9) min, />=0.0002) (Table 3). The incidence of headache was comparable in the two groups (12 vs 8%, P=0.6). Children in the prophylactic ondansetron group had significantly higher parental satisfaction scores than those in the therapeutic group (8.2 (1.8) vs 6.8 (1.7), /><0.001) (Table 3). More parents of children in the prophylactic ondansetron group had greater satisfaction (score of 7.5 or 475

4 Sennaraj et al. Table 2 Incidence and severity of PONV. Values are expressed as the number (percentage) of children PONV outcome Prophylactic group (n=75) Symptomatic treatment group (n=75) PONV incidence 2-6 h 6-24 h Nausea incidence 2-6 h 6-24 h Rescue requirements 2-6 h 6-24 h Rescue antiemetics First: ondansetron Second: metoclopramide Third: promethazine 15/75 (20%) 9/75 (12%) 14/75 (18.7%) 26/75 (34.7%) 9/44 (20.5%) 5/44 (H.4%) 9/44 (20.5%) 18/44 (40.9%) 15/75 (20%) 9/75 (12%) 14/75 (18.7%) 26/75 (34.7%) 26/75 (34.7%) 7/75 (9.3%) 2/75 (2.7%) 28/75 (37.3%) 22/75 (29.3%) 35/75 (46.7%) 54/75 (72%) 21/39 (53.8%) 17/39 (43.6%) 24/39(61.5%) 30/39 (76.9%) 28/75 (37.3%) 22/75 (29.3%) 35/75 (46.7%) 54/75 (72%) 54/75 (72%) 22/75 (29.3%) 10/75 (13.3%) Table 3 Therapeutic and pharmacoeconomic outcome measures. NNP PONV and side-effects are expressed as the number of children. Other values are expressed as mean (SD). NNP=number needed to prevent; NNT=number needed to treat; NNS=number needed to improve satisfaction; PONV=postoperative nausea and vomiting; PACU=postanaesthesia care unit; FTT=fast tracking time Outcome measure Prophylactic group («=75) Symptomatic treatment group (n=75) P FTT (min) PACU stay (min) NNP/NNT PONV NNS Parental satisfaction score Cost to benefit a child (US$) Cost per PONV-free child (US$) 21.6(4.1) (13.9) (1.8) (5.3) (30.6) Q y (1.7) _ more) than parents of children in the therapeutic ondansetron group (64 vs 25.3%, f). The positive number needed to improve satisfaction (NNS) was 3.95 in the early treatment group and 1.56 in the prophylactic group. The cost to benefit a child with ondansetron was US$17.8 in the prophylactic group and US$76.7 in the early therapeutic group. The total direct cost of all antiemetics per PONV-free child was 35.5% less with prophylactic ondansetron (US$21.3) than with early treatment (US$28.9). Discussion In our study, ondansetron administered prophylactically reduced the time to achieve fast track eligibility and the duration of PACU stay, outcomes with potential for perioperative cost reduction. Prophylactic ondansetron also improved parental satisfaction and the number needed to benefit a child. In addition, there was a significant reduction in the direct cost with the use of prophylactic ondansetron. The incidence of PONV and the need for rescue antiemetics were significantly less in the prophylactic compared with the early treatment group. The increased need for metoclopramide and promethazine as rescue antiemetics in the therapeutic ondansetron group reflects the fact that ondansetron is not as effective against established PONV as it is in preventing PONV. In this trial, the two groups were comparable with respect to patient characteristics, surgical procedure, anaesthetics, perioperative analgesics and i.v. fluids. Therefore, the difference in the outcome measures between the two groups can be attributed directly to the difference in ondansetron administration. Strabismus repair is associated with the highest risk of PONV in children. l 8 Routine prophylactic use of ondansetron has been demonstrated recently to improve true outcome measures after strabismus repair in children, as well as reducing the incidence of PONV. 1 However, prophylaxis with ondansetron in a heterogeneous (varying PONV risk) adult population undergoing ambulatory surgery has been shown not to improve outcomes after outpatient surgery compared with early symptomatic treat- 476

5 PONV and value-based anaesthesia ment. 4 Our study, in a homogeneous population of children with a high risk of PONV, demonstrated that prophylactic ondansetron was more effective than the early treatment. Most studies on PONV reported only surrogate measures, such as the incidence of PONV and the number of emetic episodes per patient. Use of surrogate outcomes alone in PONV studies has been criticized. 2 In our trial, we used parental satisfaction scores for the child's perioperative experience, the duration of PACU stay and FTT as the true outcome measures. In addition, we evaluated the number needed to treat and prevent PONV. 3 The NNT was 9 but the NNP was 2, indicating that alternate children benefited from prophylactic ondansetron. Fast tracking after general anaesthesia, which has costreducing potential, involves transferring patients directly from the operating room to a less labour-intensive stepdown unit. The time to reaching eligibility for fast tracking was shorter in the prophylactic group compared with the treatment group (Table 3). The shorter FTT in the prophylactic group can be attributed to the significant reduction in the incidence of PONV in the immediate postoperative period and the decreased need for rescue antiemetics. Transfer of patients directly from the operating room to a less labour-intensive recovery area may decrease costs The children in our study stayed in the hospital for 24 h for social and health-care access reasons and we utilized this extended stay to assess the safety of fast tracking and to assess late PONV. Early and safe fast tracking achieved with prophylactic ondansetron reveals its cost-saving potential in this high-risk population. The FTT could have been even shorter in our study had we used propofol and sevoflurane, which were not available to us at the time of this study. As it is unusual to keep children in hospital for 24 h after strabismus surgery in other parts of the world, in order to make our findings relevant to others we measured FTT and the duration of PACU stay when we analysed cost-benefit. PONV after ambulatory surgery is one of the leading causes of delay in discharge from the PACU, unanticipated hospital admission and increase in medical costs. 11 " 13 The duration of PACU stay was shorter in children who received prophylactic ondansetron and it could have been even shorter, especially in the prophylactic group, had we used criteria based on discharge alone and not fixed the minimum duration of PACU stay at 2 h (which we needed for initial evaluation of outcomes and management). We did not assess another clinically and economically important outcome, the rate of unanticipated hospital admission, as all our patients were inpatients for 24 h. Even if the children had been discharged immediately after surgery, it would have been difficult to compare the incidence of this infrequent event because of our relatively small sample size. In this era of value-conscious health care, the cost of a drug or practice to benefit a patient is a significant factor. Value-based care is essentially the best patient outcome achieved at a reasonable cost This is the first clinical trial that has evaluated the utility of prophylactic vs prompt therapeutic use of ondansetron on the basis of value-based care principles Children in the prophylactic ondansetron group had significantly higher parental satisfaction scores than those in the therapeutic group. The lower cost to benefit a child and lower cost per PONV-free child in the prophylactic ondansetron group reassert the value of prophylaxis with ondansetron as a cost-effective modality compared with early symptomatic treatment in high-risk patients. Even though prophylactic ondansetron was a costeffective approach, the higher cost of ondansetron has been a major concern. Recently, it has been demonstrated that prophylactic dexamethasone administered at induction is cost-effective in managing PONV after paediatric strabismus repair. 16 However, as a sole prophylactic antiemetic, neither dexamethasone nor ondansetron was adequate to eliminate PONV completely in this high-risk population. 16 Scuderi and colleagues have recently shown that multimodal management of PONV decreases the incidence of PONV better than prophylactic ondansetron alone in a population with a high risk of PONV. 17 For an individual patient, the use of routine prophylactic ondansetron compared with 'wait and treat' may increase the direct drug costs. However, we believe that the 'downstream benefits' (higher patient satisfaction, earlier fast tracking and shorter PACU stay) more than compensated for the additional cost. References 1 Sadhasivam S, Shende D, Madan R. Prophylactic ondansetron in prevention of postoperative nausea and vomiting following pediatric strabismus surgery: a dose response study. Anesthesiology 2000; 92: Fisher DM. The 'big little problem' of postoperative nausea and vomiting: do we know the answer yet? Anesthesiology 1997; 87: Laupacis A, Sackett DL, Roberts RS. An assessment of clinically useful measures of the consequences of treatment. N Engl J Med 1988; 318: Scuderi PE, James RL, Harris L, Mims GR. Antiemetic prophylaxis does not improve outcomes after outpatient surgery when compared to symptomatic treatment. Anesthesiology 1999; 90: Aldrete JA. The post-anesthesia recovery score revisited. J Gin Anesth 1995; 7: White PF, Song D. New criteria for fast tracking after outpatient anesthesia: a comparison with the modified Aldrete's scoring system. Anesth Analg 1999; 88: Pawar DK. Pain management. In: Brown TCK, Fisk GC, eds. Anaesthesia for Children, 2nd edn. Melbourne: Blackwell Scientific Publications, 1992; Watcha MF, Bras PJ, Cieslak GD, Pennant JH. The doseresponse relationship of ondansetron in preventing postoperative emesis in pediatric patients undergoing ambulatory surgery. Anesthesiology 1995; 82: Watcha MF, White PF. Economics of anesthetic practice. Anesthesiology 1997; 86: I

6 Sennaraj et al. 10 Dexter F, Tinker JH. Analysis of strategies to decrease postanesthesia care unit costs. Anesthesiology 1995; 82: I I Gold BS, Kitz DS, Lecky JH, Neuhaus JM. Unanticipated admission to the hospital following ambulatory surgery. JAMA 1989; 262: Cohen MM, Cameron CB, Duncan PG. Pediatric anesthesia morbidity and mortality in the perioperative period. Anesth Analg 1990; 70: Patel Rl, Hannallah RS. Anesthetic complications following pediatric ambulatory surgery: a 3-yr study. Anesthesiology 1988; 69: Orkin FK. Moving toward value-based anesthesia care. J Clin Anesth 1993; 5: Johnstone RE. From economics to ethics: values-based anesthesia. J Clin Anesth 1999; II: Subramaniam B, Madan R, Sadhasivam S, et al. Dexamethasone is a cost-effective alternative to ondansetron in preventing PONV after paediatric strabismus repair. BrJ Anaesth 2001; 86: Scuderi PE, James RL, Harris L, Mims GR. Multimodal antiemetic management prevents early postoperative vomiting after outpatient laparoscopy. Anesth Analg 2000; 91:

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