Management of Reflux and GORD 1a 2a Title of Guideline (must include the word Guideline (not protocol, policy, procedure etc) Contact Name and Job Title (author) Directorate & Speciality Guideline for the Management of Reflux and GORD in Paediatrics Amy-Jo Hooley, Specialist Clinical Pharmacist Paediatric Gastroenterology Date of submission Mar - 2016 Date on which guideline reviewed Mar - 2019 Explicit definition of patient group to which it applies (e.g. inclusion and exclusion criteria, diagnosis) Abstract All under 19 years with a clinical diagnosis of either gastro-oesophageal reflux disease or milder refluxing disease within the Children s Hospital A clinical guideline to look at the management of children and babies that present with reflux and gasto oesophageal reflux disease. Key Words Paediatric, reflux, GORD Statement of the evidence base of the guideline has the guideline been peer reviewed by colleagues? meta analysis of randomised controlled Designed in conjunction with NICE guideline as per trials published Jan 2015. at least one well-designed controlled study without randomisation Evidence as per Cochrane review Pharmacological treatment of Children with gastroesophageal disease 2014 2b at least one other type of well-designed quasi-experimental study 3 well designed non-experimental descriptive studies (ie comparative / correlation and case studies) 4 expert committee reports or opinions and / or clinical experiences of respected authorities 5 recommended best practise based on the clinical experience of the guideline developer Consultation Process Paediatric Guideline Process Target audience Nottingham Children s Hospital This guideline has been registered with the trust. However, clinical guidelines are guidelines only. The interpretation and application of clinical guidelines will remain the responsibility of the individual clinician. If in doubt contact a senior colleague or expert. Caution is advised when using guidelines after the review date. Amy-Jo Hooley Page 1 of 10 May 2016
Document Control Document Amendment Record Version Issue Date Lead Author Description 1 May 2016 Amy-Jo Hooley GORD guideline incorporating the new PPI choice of lansoprazole General Notes: Statement of Compliance with Child Health Guidelines SOP This guideline has followed Child Health Guideline SOP. It has been circulated to all Paediatric Senior staff and comments incorporated before uploading to the Trust Guideline site. Martin Hewitt Clinical Guideline Lead 17 May 2015 Amy-Jo Hooley Page 2 of 10 May 2016
Introduction Gastro-oesophageal reflux (GOR) is the passage of gastric contents into the oesophagus. It is a common physiological event that can happen at all ages from infancy to old age, and is often asymptomatic. It occurs more frequently after feeds/meals. In many infants, GOR is associated with a tendency to 'overt regurgitation' the visible regurgitation of feeds. Gastro-oesophageal reflux disease (GORD) refers to gastro-oesophageal reflux that causes symptoms (for example, discomfort or pain) severe enough to merit medical treatment, or to gastro-oesophageal reflux-associated complications (such as oesophagitis or pulmonary aspiration). Parents should be advised that GOR is quite normal. In fact it: is very common (it affects at least 40% of infants) usually begins before the infant is 8 weeks old may be frequent (5% of those affected have 6 or more episodes each day) usually becomes less frequent with time (it resolves in 90% of affected infants before they are 1 year old) does not usually need further investigation or treatment. When reassuring parents and carers about regurgitation, advise them that they should return for review if any of the following red flag symptoms occur: the regurgitation becomes persistently projectile there is bile-stained (green or yellow-green) vomiting or haematemesis (blood in vomit) there are new concerns, such as signs of marked distress, feeding difficulties or inadequate weight gain there is persistent, frequent regurgitation beyond the first year of life. Assessment Gastro-oesophageal reflux disease recognition and diagnosis It is not routine to treat for GOR if an infant or child without overt regurgitation, presents with only 1 of the following symptoms: e, refusing to feed, gagging or choking) Consider referring infants and children with persistent back arching or features of Sandifer s syndrome (episodic torticollis with neck extension and rotation) for specialist assessment. Amy-Jo Hooley Page 3 of 10 May 2016
Recognise the following as possible complications of GOR in infants, children and young people: example, more than 3 episodes in 6 months) cerebral palsy. Recognise the following as possible symptoms of GOR in children and young people: epigastric pain Be aware that GOR is more common in children and young people with asthma, but it has not been shown to cause or worsen it. Be aware that some symptoms of a non-ige-mediated cows milk protein allergy can be similar to the symptoms of GORD, especially in infants with atopic symptoms, signs and/or a family history. If a non-ige- mediated cows milk protein allergy is suspected, see the NICE guideline on food allergy in children and young people. When deciding whether to investigate or treat, take into account that the following are associated with an increased prevalence of GORD: GOR only rarely causes episodes of apnoea or apparent life-threatening events (ALTEs), but consider referral for specialist investigations if it is suspected as a possible factor following a general paediatric assessment. Arrange an urgent specialist hospital assessment to take place on the same day for infants younger than 2 months with progressively worsening or vomiting of feeds, that could suggest pyloric stenosis. Amy-Jo Hooley Page 4 of 10 May 2016
The following symptoms are classified by NICE as Red Flag symptoms. Any patient that presents with these symptoms requires urgent assessment: Symptoms and signs Possible diagnostic implications Suggested actions Gastrointestinal Frequent, forceful (projectile) vomiting Bile-stained (green or yellow-green) vomit Haematemesis (blood in vomit) with the exception of swallowed blood, for example, following a nose bleed or ingested blood from a cracked nipple in some breast-fed infants May suggest hypertrophic pyloric stenosis in infants up to 2 months old May suggest intestinal obstruction May suggest an important and potentially serious bleed from the oesophagus, stomach or upper gut Paediatric surgery referral Paediatric surgery referral Onset of regurgitation and/or vomiting after 6 months old or persisting after 1 year old Blood in stool Late onset suggests a cause other than reflux, for example a urinary tract infection (also see the NICE guideline on urinary tract infection in children) Persistence suggests an alternative diagnosis May suggest a variety of conditions, including bacterial gastroenteritis, infant cows' milk protein allergy (also see the NICE guideline on food allergy in children and young people) or an acute surgical condition Urine microbiology investigation Stool microbiology investigation Amy-Jo Hooley Page 5 of 10 May 2016
Abdominal distension, tenderness or palpable mass Chronic diarrhoea May suggest intestinal obstruction or another acute surgical condition May suggest cows' milk protein allergy (also see the NICE guideline on food allergy in children and young people) Paediatric surgery referral Systemic Appearing unwell Fever Dysuria Bulging fontanelle Rapidly increasing head circumference (more than 1 cm per week) Persistent morning headache, and vomiting worse in the morning May suggest infection (also see the NICE guideline on feverish illness in children) May suggest urinary tract infection (also see the NICE guideline on urinary tract infection in children) May suggest raised intracranial pressure, for example, due to meningitis (also see the NICE guideline on bacterial meningitis and meningococcal septicaemia) May suggest raised intracranial pressure, for example, due to hydrocephalus or a brain tumour Clinical assessment and urine microbiology investigation Clinical assessment and urine microbiology investigation Altered responsiveness, for example, lethargy or May suggest an illness such as meningitis (also see the NICE guideline Amy-Jo Hooley Page 6 of 10 May 2016
irritability Infants and children with, or at high risk of, atopy on bacterial meningitis and meningococcal septicaemia) May suggest cows' milk protein allergy (also see the NICE guideline on food allergy in children and young people) Pharmacological Management: 1. First line treatment in all children should be compound alginate preparations. For children under 2 years this would be gaviscon infant sachets, or for older children Peptac. (Note gaviscon has quite a high sodium content therefore its use should be carefully considered before giving to some patient groups such as renal patients). Children under 4.5kg should have 1 dose of gaviscon infant with feeds up to 6 times a day. Children over 4.5kg should have 2 doses of gavison infant with feeds up to 6 times a day. Children over 2 years of age can receive gaviscon or peptac as per the BNF-C (un-licensed in children < 6 years). 2. Second line treatment should be a FOUR week trial of ranitidine. A recommended dose of ranitidine would be: 2-3mg/kg three times a day for children < 6months, and 2-3mg/kg twice a day for children >6 months. For renal dosing please see the BNF-C 3. A proton pump inhibitor should be a third line choice after ranitidine has been trialled. Proton pump inhibitors PPIs block acid secretion by irreversibly binding to and inhibiting the hydrogen-potassium ATPase pump that resides on the luminal surface of the parietal cell membrane. The drugs in this class include omeprazole and lansoprazole. Amy-Jo Hooley Page 7 of 10 May 2016
The proton pump inhibitor of choice is Lansoprazole Fastabs. Fastabs can be used in children unable to swallow tablets, and the dose is 1mg/kg/day in children up to 30kg (maximum 15mg per day). Children over 30kg 15-30mg per day. Please check the BNF-C for the most up to date dosing. Please not ONLY Lansoprazole Fastab brand should be prescribed, as the generic orodispersible lansoprazole is not suitable for dose administration. The trust is no longer recommending omeprazole in infants as many GP s are unwilling to prescribe the omeprazole suspension due to their being no licensed product available, and omeprazole MUPs are neither suitable nor licensed to be administered via feeding tubes. For children under 15kg weight, a 15mg lansoprazole fastab tablet can be dissolved in 15ml of water and an equivalent dose can be administered in mg/ml. Dosing guidelines for PPIs vary considerably. Infants and younger children appear to metabolize some PPIs more rapidly and may require higher perkilogram dosing than older individuals. However, they should be used with caution in infants because of low efficacy in those with uncomplicated reflux symptoms, and also because the pharmacokinetics of PPIs may be affected by immature cytochrome metabolism in young infants. After a 4 week trial of the Lansoprazole and Ranitidine, consider referral to a specialist for possible endoscopy if the symptoms: do not resolve or recur after stopping the treatment. 4. Routine treatment with domperidone (see MHRA warning: http://www.mhra.gov.uk/home/groups/commsic/documents/drugsafetymessage/con465933.pdf, erythromycin or metoclopramide is not recommended for children with GOR/GORD. If symptoms persist, then these drugs should only be considered by a specialist gastroenterologist, and after consideration of the drug s potential side effect profile. Amy-Jo Hooley Page 8 of 10 May 2016
Non-Pharmacological Management Occasionally in severe instances of GORD it may be necessary to feed the child via the enteral route in an attempt to control symptoms. Only consider enteral tube feeding to promote weight gain in infants and children with overt regurgitation and faltering growth if: xplored and/or unsuccessful Before starting enteral tube feeding for infants and children with faltering growth associated with overt regurgitation, agree in advance: ividualised nutrition plan At this point it is imperative that the dietitian is involved in the patients care. In infants and children receiving enteral tube feeding for faltering growth associated with overt regurgitation: achieved and that appropriate weight gain is sustained Consider jejunal feeding for infants, children and young people: because of regurgitation or reflux-related pulmonary aspiration is a concern. Fundoplication Offer an upper GI endoscopy with oesophageal biopsies for infants, children and young people before deciding whether to refer for surgical opinion on fundoplication for presumed GORD. Consider performing other investigations such as an oesophageal ph study (or combined oesophageal ph and impedance monitoring if available) and an upper GI contrast study for infants, children and young people before deciding whether to offer fundoplication. NICE recommends referral for fundoplication in infants, children and young people with severe, intractable GORD if: example, in the case of long-term, continuous, thickened enteral tube feeding. Amy-Jo Hooley Page 9 of 10 May 2016
References: Vandenplas Y, Rudolph CD, Di Lorenzo C, et al. Pediatric gastroesophageal reflux clinical practice guidelines: joint recommendations of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN). J Pediatr Gastroenterol Nutr 2009; 49:498. Litalien C, Théorêt Y, Faure C. Pharmacokinetics of proton pump inhibitors in children. Clin Pharmacokinet 2005; 44:441. Ward RM, Kearns GL. Proton pump inhibitors in pediatrics : mechanism of action, pharmacokinetics, pharmacogenetics, and pharmacodynamics. Paediatr Drugs 2013; 15:119. BNF-C 2014-2015 as accesed via www. medicinescomplete.com Dec 2015 Gastro Oesophageal Reflux Disease in Children and Young People NICE guideline as published Jan 2015 accessed via: http://www.nice.org.uk/guidance/ng1/evidence/fullguideline-1784557 Amy-Jo Hooley Page 10 of 10 May 2016