116 Hyoscine butylbromide (Buscopan) for abdominal pain in children: a randomized controlled trial

Abdominal pain is one of the most frequent reasons for an emergency department (ED) visit. Most cases are functional and no therapy has proven effective. The purpose of this study is to identify an effective therapeutic agent for children who present to the ED with presumed functional abdominal pain. We sought to determine if hyoscine butylbromide (HBB) (BuscopanTM) is effective for children who present to the ED with functional abdominal pain. We conducted a randomized, blinded, superiority trial comparing HBB 10 mg plus acetaminophen placebo to oral acetaminophen 15 mg/kg (max 975 mg) plus HBB placebo using a double-dummy approach. We included children 8–17 years presenting to the ED with colicky abdominal pain rated > 40 mm on a 100 mm visual analog scale (VAS). The primary outcome was VAS pain score at 80 minutes post-administration. Secondary outcomes included adverse effects; caregiver satisfaction with pain management using a five-item Likert scale; recidivism and missed surgical diagnoses within 24-hours of discharge. Analysis was based on intention to treat. 236 participants were randomized (116 acetaminophen; 120 HBB). The mean (SD) age was 12.4 (3.0) years and 153/236 (64.8%) were female. The median (IQR) duration of pain prior to enrollment was 2 (4.5) hours and analgesia was provided to 129/236 (54.7%) of participants. The mean (SD) pre-intervention pain scores in the acetaminophen and HBB groups were 62.3 (16.5) mm and 60.3 (17.9) mm, respectively. At 80 minutes, the mean (SD) pain scores in the acetaminophen and HBB groups were 30.1 (28.8) mm and 29.4 (26.4) mm, respectively and there were no significant differences adjusting for pre-intervention scores (p=0.96). The median (IQR) caregiver satisfaction was high in the acetaminophen [5 (2)] and HBB [5 (1)] groups (p=0.79). The median (IQR) length of stay between acetaminophen [236 (99.75)] and HBB [230.5 (102.5)] was not significantly different (p=0.91). In the acetaminophen and HBB groups, 6 and 8 participants returned to a health provider, of which 4/6 and 6/8 returned with abdominal pain, respectively. There were no missed surgical diagnoses. The most common adverse effect was nausea (9% per group) and there were no significant differences in adverse effects between acetaminophen (28/116, 24.1%) and HBB (32/120, 26.7%) (p=0.57). For children with presumed functional abdominal pain who present to the ED, both acetaminophen and HBB produce a clinically important (VAS <30 mm) reduction in pain and should be routinely considered in this clinical setting.

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