Clinical Trial: Buscopan Versus Acetaminophen for Acute Abdominal Pain in Children

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Hyoscine Hydrobromide (Buscopan) Versus Acetaminophen for Acute Abdominal Pain in Children: A Randomized Controlled Trial

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.

Detailed Summary: Acute abdominal pain is a common complaint among paediatric patients visiting the emergency department (ED). Functional abdominal pain is not associated with any surgical or infectious etiology and is a frequent cause of painful abdominal cramps. Although functional abdominal pain is not life-threatening, it has significant impact on quality of life, functional outcomes, and patient satisfaction. It is a major source of school and work absence, loss of sleep, and extracurricular impairment. Despite this, analgesia has traditionally been withheld from patients with acute abdominal pain. The reasons behind this are likely two-fold. First, there is good evidence that clinicians fear that analgesia will mask signs of an underlying surgical pathology such as appendicitis. There is no current published literature that supports this practice. In fact, recent evidence has found that providing analgesia to children does not obscure signs of an acute surgical abdomen nor lead to clinically significant differences in negative outcomes. Second, there is no standard of care specifying the best analgesic options for treating abdominal pain in children in the post-codeine era. Although acetaminophen, ibuprofen, ketorolac, buscopan, and almagel/viscous lidocaine are frequently used agents in the ED, evidence for their benefit in children with functional abdominal pain is lacking. As a predictable result, most patients who present with abdominal pain fail to experience pain relief at discharge. The importance of providing optimal pain treatment is echoed by several national and international level policy statements. In addition to the World Health Organization (WHO)'s mandate that adequate pain treatment should be a fundamental human right, the American Academy of Pediatrics (AAP) has reaffirmed its position that adequate analgesia be provided for children. Furthermore, literature supports that providing analgesia improves patient care, caregiver satisfaction, and the therapeutic re
Sponsor: Lawson Health Research Institute

Current Primary Outcome: Analgesic Efficacy [ Time Frame: 80 minutes post-intervention ]

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


Original Primary Outcome: Analgesic Efficacy [ Time Frame: 60 minutes post-intervention ]

Post - pre-intervention Faces Pain Scale - Revised


Current Secondary Outcome:

  • Analgesic Efficacy [ Time Frame: 15 minutes post-intervention ]
    Pain severity on Faces Pain Scale - Revised and VAS
  • Analgesic Efficacy [ Time Frame: 30 minutes post-intervention ]
    Pain severity on Faces Pain Scale - Revised and VAS
  • Analgesic Efficacy [ Time Frame: 45 minutes post-intervention ]
    Pain severity on Faces Pain Scale - Revised and VAS
  • Analgesic Efficacy [ Time Frame: 60 minutes post-intervention ]
    Pain severity on Faces Pain Scale - Revised and VAS
  • Need for Rescue Analgesia [ Time Frame: 80 minutes post-intervention ]
    Frequency of rescue analgesia
  • Time to Analgesia [ Time Frame: 80 minutes post-intervention ]
    Time to Achieve 20% Reduction in Faces Pain Score - Revised from time 0
  • Adequacy of Sedation [ Time Frame: 80 minutes post-intervention ]
    Proportion of participants that achieve a pain score < 30 mm on the VAS
  • Adverse Effects [ Time Frame: 80 minutes post-intervention ]
    Frequency of Adverse Effects
  • Caregiver Satisfaction [ Time Frame: 80 minutes post-intervention ]
    Satisfaction scores on 5-Item Likert Scale
  • Return visits [ Time Frame: 72 hours post discharge ]
    Proportion of participants with return visits for surgical pathology


Original Secondary Outcome:

  • Analgesic Efficacy [ Time Frame: 15 minutes post-intervention ]
    Post - pre-intervention Faces Pain Scale - Revised
  • Analgesic Efficacy [ Time Frame: 30 minutes post-intervention ]
    Post - pre-intervention Faces Pain Scale - Revised
  • Analgesic Efficacy [ Time Frame: 45 minutes post-intervention ]
    Post - pre-intervention Faces Pain Scale - Revised
  • Need for Rescue Analgesia [ Time Frame: 60 minutes post-intervention ]
    Frequency of rescue analgesia
  • Time to Analgesia [ Time Frame: 60 minutes post-intervention ]
    Time to Achieve 20% Reduction in Pre-Intervention Faces Pain Score - Revised
  • Adverse Effects [ Time Frame: 60 minutes post-intervention ]
    Frequency of Adverse Effects
  • Caregiver Satisfaction [ Time Frame: 60 minutes post-intervention ]
    Satisfaction scores on 5-Item Likert Scale


Information By: Lawson Health Research Institute

Dates:
Date Received: October 13, 2015
Date Started: March 20, 2017
Date Completion: August 2018
Last Updated: May 8, 2017
Last Verified: March 2017