Buscopan Versus Acetaminophen for Acute Abdominal Pain in Children
Condition: Abdomen, Acute; Children
MeSH terms: Abdominal Pain; Abdomen, Acute
Study type: Interventional
Phase: Phase 3

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 description: 
      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 relationship. Antispasmodics are commonly used agents to treat abdominal
      cramping. Hyoscine butylbromide (HBB), trade name: Buscopan, is an anticholinergic agent that
      when orally administered, does not cross the blood brain barrier and has minimal systemic
      absorption. Therefore, it inhibits bowel motility without central nervous system or
      peripheral side effects. This antispasmodic has been used in clinical practice for over 60
      years and specifically has been on the market since 1952 for the treatment of abdominal
      cramps. It is widely available around the world as both a prescription drug and an over the
      counter medication in many industrialized countries. It has also been used safely in neonates
      and children. As hyoscine butylbromide is barely absorbed, it is generally well tolerated. In
      the two large-scale studies of almost 1200 patients that compared HBB with placebo (and
      paracetamol), there was no significant difference in adverse events between the two groups,
      including those commonly associated with anticholinergics, such as nausea, constipation, dry
      mouth, blurred vision, tachycardia and urinary retention. Moreover, these adverse events not
      only occurred at a low incidence (less than or equal to 1.5%) but were also usually mild and
      self-limiting. In abdominal cramping and pain associated with irritable bowel syndrome,
      systematic reviews have had conflicting results with regards to analgesic efficacy, primarily
      because of small sample sizes and less rigorous designs. Muller-Krampe et al. conducted a
      prospective cohort of over 200 children with both acute and chronic abdominal spasms and
      compared the effectiveness of oral HBB 10 mg to a homeopathic preparation. HBB demonstrated
      comparative improvements to the homeopathic preparation with respect to pain, sleep
      disturbance, eating and drinking, and crying. Over 90% of patients in both groups reported
      good tolerability and there were no adverse events. Although HBB is used widely for abdominal
      pain in children and anecdotal evidence suggests it is efficacious, no paediatric clinical
      trial to date has explored its efficacy in the ED setting. The investigators hypothesize that
      HBB will have superior efficacy to the most commonly used agent, acetaminophen for acute
      abdominal pain in children. If HBB is found to be an effective analgesic in children with
      acute abdominal pain, it could provide a therapeutic option for a common, painful condition
      for which there is currently very little to offer.
    

Intervention name(s): Acetaminophen, Analgesics, Non-Narcotic; Hyoscine butylbromide, Analgesics, Non-Narcotic
Intervention type(s): Drug; Drug
Intervention description(s): Oral single dose; Oral single dose
Other intervention name(s): Tylenol; Buscopan
Intervention MeSH terms: Acetaminophen; Scopolamine; Analgesics, Non-Narcotic; Analgesics; Butylscopolammonium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment