Buscopan Versus Acetaminophen for Acute Abdominal Pain in Children

• Status: Completed
• Trial end date: 2019-02-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lawson Health Research Institute
• Treatments: Acetaminophen; Analgesics; Analgesics, Non-Narcotic; Butylscopolammonium Bromide; Scopolamine; Scopolamine Hydrobromide

Criteria

Inclusion Criteria:

• All children aged 8-17 years presenting to the paediatric ED with:

1. A chief complaint of colicky abdominal pain AND

2. Pain score of at least 4/10 on the Faces Pain Scale - Revised AND

3. A presumed non-surgical etiology

Exclusion Criteria:

1. Prior abdominal surgery

2. Concomitant use of other anticholinergic medication including but not limited to tricyclic antidepressants, antihistamines, benztropine mesylate

3. Signs and symptoms consistent with a bowel obstruction

4. Peritoneal signs

5. Suspected previous hypersensitivity reaction to either acetaminophen or HBB

6. Suspected appendicitis

7. History of abdominal trauma within 48 hours of presentation

8. Unstable vital signs

9. History of bowel obstruction

10. Myasthenia gravis

11. Fever (aural temperature > 38.2 C)

12. Chronic liver disease

13. Persistent vomiting despite administration of oral anti-emetic

14. Symptoms and signs consistent with a urinary tract infection

15. Symptoms and signs consistent with a toxin ingestion

16. Symptoms and signs consistent with gynecological or gonadal pathology

17. Symptoms and signs consistent with vasoocclusive crisis in a patient with a hemoglobinopathy