Buscopan Versus Acetaminophen for Acute Abdominal Pain in Children

NCT02582307 | Completed Phase 3

• 1 other identifier: 107243
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

Brief Summary

There is ample evidence that pain in children is under recognized and under treated. This is especially true for acute abdominal pain, a common complaint in the paediatric emergency department. Clinicians often fear that analgesia will obscure the diagnosis of a potentially surgical condition. As a result, acute abdominal pain goes untreated in many children, as there is no standard of care. Hyoscine N-butylbromide (Buscopan) has been used successfully in adults and children for pain associated with urinary tract infections and kidney stones for over 60 years. However, no study has explored its usefulness in relieving acute abdominal pain in children. The objectives of this study are to investigate to what degree Buscopan is effective in relieving abdominal pain in children compared to acetaminophen.

Conditions

Abdomen, Acute; Children

Outcome Measures

Primary Outcomes (1)

• Analgesic Efficacy

  Pain severity on a 100 mm Visual Analog Scale (VAS)

  80 minutes post-intervention

Secondary Outcomes (10)

• Analgesic Efficacy

  15 minutes post-intervention

• Analgesic Efficacy

  30 minutes post-intervention

• Analgesic Efficacy

  45 minutes post-intervention

• Analgesic Efficacy

  60 minutes post-intervention

• Need for Rescue Analgesia

  80 minutes post-intervention

Study Arms (2)

Hyoscine butylbromide

EXPERIMENTAL

Hyoscine butylbromide 10mg oral single dose

Drug: Hyoscine butylbromide, Analgesics, Non-Narcotic

Acetaminophen

ACTIVE COMPARATOR

Acetaminophen 15mg/kg oral single dose (maximum 1000mg)

Drug: Acetaminophen, Analgesics, Non-Narcotic

Interventions

Acetaminophen, Analgesics, Non-Narcotic DRUG

Oral single dose

Also known as: Tylenol

Acetaminophen

Hyoscine butylbromide, Analgesics, Non-Narcotic DRUG

Oral single dose

Also known as: Buscopan

Hyoscine butylbromide

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All children aged 8-17 years presenting to the paediatric ED with:
• A chief complaint of colicky abdominal pain AND
• Pain score of at least 4/10 on the Faces Pain Scale - Revised AND
• A presumed non-surgical etiology

You may not qualify if:

• Prior abdominal surgery
• Concomitant use of other anticholinergic medication including but not limited to tricyclic antidepressants, antihistamines, benztropine mesylate
• Signs and symptoms consistent with a bowel obstruction
• Peritoneal signs
• Suspected previous hypersensitivity reaction to either acetaminophen or HBB
• Suspected appendicitis
• History of abdominal trauma within 48 hours of presentation
• Unstable vital signs
• History of bowel obstruction
• Myasthenia gravis
• Fever (aural temperature \> 38.2 C)
• Chronic liver disease
• Persistent vomiting despite administration of oral anti-emetic
• Symptoms and signs consistent with a urinary tract infection
• Symptoms and signs consistent with a toxin ingestion

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A5W9, Canada

Location

Related Publications (1)

• Poonai N, Kumar K, Coriolano K, Thompson G, Brahmbhatt S, Dzongowski E, Stevens H, Gupta P, Miller M, Elsie S, Ashok D, Joubert G, Lim R, Butter A, Ali S. Hyoscine butylbromide versus acetaminophen for nonspecific colicky abdominal pain in children: a randomized controlled trial. CMAJ. 2020 Nov 30;192(48):E1612-E1619. doi: 10.1503/cmaj.201055.

  PMID: 33257343 DERIVED

MeSH Terms

Conditions

Abdomen, Acute

Interventions

Acetaminophen; Analgesics; Butylscopolammonium Bromide

Condition Hierarchy (Ancestors)

Abdominal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Quaternary Ammonium Compounds; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Naveen Poonai, MD

  Western University Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2015
• First Posted: October 21, 2015
• Study Start: March 20, 2017
• Primary Completion: December 3, 2018
• Study Completion: February 22, 2019
• Last Updated: May 2, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)