Aim  To determine whether there is robust evidence of efficacy for domperidone in reducing the symptoms of gastro‐oesophageal reflux (GOR) and gastro‐oesophageal reflux disease (GORD) in children. Methods  Systematic review of randomized controlled trials (RCTs). A search was made of the Cochrane Library Issue 2004 (Central Register of Controlled Trials and Database of Systematic Reviews), Medline (Pub‐med) 1966 to present and Embase from 1974 to 2004, and reference citations of the RCTs that had been found electronically. Results  Four RCTs were identified. Only the two older trials showed any benefits of domperidone on clinical symptoms of GORD in older children, which were the primary outcome measures. In the trial undertaken by Clara, a good or excellent result was obtained in 93% of the domperidone group compared with 33% of the controls (P < 0.05). In the trial undertaken by de Loore, after 2 weeks of treatment 75% of patients treated with domperidone were found not to be vomiting, compared with 43% in the metoclopramide group and 7% in the placebo group. The trial by Corraccio gave no detailed results regarding the primary outcomes of effect of domperidone on symptoms but simply reported ‘cured’, ‘improved’ or ‘unchanged’. The secondary pH‐metric outcome of the number of reflux episodes, was reduced with domperidone. Conclusion  From the limited evidence available, there was no robust evidence of efficacy for the treatment of GOR with domperidone in young children. Given the usually benign nature of the condition, the widespread use of unlicensed medicines for GOR is not warranted.

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Background Diclofenac is commonly used for acute pain in children, but is not licensed for this indication in all age groups. Objectives 1) Assess the efficacy of diclofenac for acute pain in children. 2) Assess the safety of diclofenac for short‐term use in children. 3) Identify gaps in the evidence to direct future research. Search strategy Seventeen databases indexing clinical trial reports were searched in February 2005 (with an update search as part of this first review in May 2008). A hand search of Paediatric Anaesthesia was undertaken and summaries obtained of adverse reaction reports from the UK Yellow Card Scheme and World Health Organization (WHO) Monitoring Centre. The reference lists of included studies were also searched. Selection criteria Any published report, in any language, involving the administration of diclofenac to a patient aged 18 years or younger for acute pain and detailing either monitoring of efficacy or safety. Data collection and analysis Two review authors independently assessed study quality and extracted the data. Authors were contacted where necessary. Review Manager version 5 was used for analysis. Main results 1) Efficacy: randomised controlled trials (RCTs) comparing diclofenac with placebo/any other treatment by using pain scores (assessed or reported), or need for rescue analgesia. 2) Safety: any type of study seeking adverse events (regardless of cause). An adverse event was defined as any reported adverse or untoward happening to a patient being treated with diclofenac for acute pain. Seven publications on diclofenac efficacy and 79 on safety (74 studies plus five case reports) were included in the final analysis. Compared with placebo/no treatment, diclofenac significantly reduced need for post‐operative rescue analgesia (relative risk [RR] 0.6; number needed to treat to benefit [NNT] 3.6; 95% confidence interval [CI] 2.5 to 6.3). Compared with any other non‐NSAID, patients receiving diclofenac suffered less nausea or vomiting, or both (RR 0.6; NNT 7.7 [5.3 to 14.3]). There appeared to be no increase in bleeding requiring surgical intervention in patients receiving diclofenac in the peri‐operative period. Serious diclofenac adverse reactions occurred in fewer than 0.24% of children treated for acute pain. The types of serious adverse reactions were similar to those reported in adults. Authors' conclusions Diclofenac is an effective analgesic for perioperative acute pain in children. It causes similar types of serious adverse reactions in children as in adults, but these are rare. More research on optimum dosing and safety in asthmatic children is required. PLAIN LANGUAGE SUMMARY Diclofenac for pain relief in children Diclofenac is commonly used for short‐term pain relief in children, particularly around the time of surgery. There is good evidence that diclofenac is effective for pain relief in adults, and side effects such as stomach upset are well known. However, developmental differences mean that children may sometimes react differently to medicines than adu...

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