Hyoscine butylbromide versus acetaminophen for nonspecific colicky abdominal pain in children: a randomized controlled trial

BACKGROUND:Less than two-thirds of children with abdominal pain in the emergency department receive analgesia. We sought to determine whether hyoscine butylbromide was superior to acetaminophen for children with nonspecific colicky abdominal pain.METHODS:We randomly allocated children aged 8–17 years with nonspecific colicky abdominal pain who presented to the pediatric emergency department of London Health Sciences Centre, London, Ontario to receive hyoscine butylbromide, 10 mg given orally, or acetaminophen, 15 mg/kg given orally (maximum 975 mg). We considered the minimal clinically important difference for the primary outcome (self-reported pain at 80 min) to be 13 mm on a 100 mm visual analogue scale. Secondary outcomes included administration of rescue analgesia, adverse effects and pain score less than 30 mm at 80 minutes.RESULTS:A total of 236 participants (120 in the hyoscine butylbromide group and 116 in the acetaminophen group) were included in the trial. The mean visual analogue scale scores at 80 minutes were 29 mm (standard deviation [SD] 26 mm) and 30 mm (SD 29 mm) with hyoscine butylbromide and acetaminophen, respectively (adjusted difference 1, 95% confidence interval −7 to 7). Rescue analgesia was administered to 4 participants (3.3%) in the hyoscine butylbromide group and 1 participant (0.9%) in the acetaminophen groups (p = 0.2). We found no significant differences in rates of adverse effects between hyoscine butylbromide (32/116 [27.6%]) and acetaminophen (28/115 [24.3]) (p = 0.5); no serious adverse effects were observed. The proportion with a pain score less than 30 mm at 80 minutes was 66 (55.0%) with hyoscine butylbromide and 63 (54.3%) with acetaminophen (p = 0.9).INTERPRETATION:Hyoscine butylbromide was not superior to acetaminophen in this setting. Both agents were associated with clinically important pain reduction, and either can be considered for children presenting to the emergency department with nonspecific colicky abdominal pain. Trial registration: Clinicaltrials.gov, no. {"type":"clinical-trial","attrs":{"text":"NCT02582307","term_id":"NCT02582307"}}NCT02582307

Abdominal pain is reported by a third of school-aged children¹ and accounts for several visits daily in most emergency departments.^2–5 Although the use of analgesia to treat acute abdominal pain is well-supported,^6,7 there is little evidence to guide the management of nonspecific abdominal pain in the emergency department,⁸ which accounts for two-thirds of cases of abdominal pain presenting to the emergency department.^8,9 Acetaminophen is the most commonly used World Health Organization Step 1 analgesic.¹⁰ In children, it is effective for many painful conditions,^11,12 but data supporting its use for abdominal pain are lacking.^13,14 Despite strong advocacy by the American Academy of Pediatrics¹⁵ for adequate pain management, less than two-thirds of children with abdominal pain in the emergency department receive analgesia,^16,17 and roughly half experience ongoing pain after discharge. ¹⁸ Children with nonspecific abdominal pain are less likely than those with a specific cause to receive analgesia.⁵ Available analgesic options for children with nonspecific abdominal pain in the emergency department may result in greater adherence to the American Academy of Pediatrics recommendations.Hyoscine butylbromide is orally administered and available in most Canadian emergency departments. We surmised that it may be effective for colicky abdominal pain owing to its antispasmodic properties.¹⁹ Ten placebo-controlled studies involving 3699 adults with functional abdominal pain showed hyoscine butylbromide to be beneficial, without serious adverse effects.^20–29 In the only pediatric study, hyoscine butylbromide, 10 mg given orally, was found to be beneficial compared to a homeopathic preparation in 204 children, with no serious adverse effects.³⁰ We sought to determine whether hyoscine butylbromide was superior to acetaminophen in relieving pain among children presenting to the emergency department with nonspecific colicky abdominal pain.