A Placebo-controlled Crossover Trial Using Cyproheptadine To Treat Children With Functional Abdominal Pain
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain, Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 8 - 18 |
| Updated: | 4/2/2016 |
| Start Date: | August 2012 |
| End Date: | August 2013 |
| Contact: | Emilia Mondragon |
| Email: | emondrag@med.umich.edu |
The investigators hypothesize that using Cyproheptadine in a placebo-controlled crossover
trial would help relieve abdominal pain associated with FAP in children, achieving a greater
response than that observed with placebo. In addition to assessing self-report of pain and
other symptoms, the investigators also propose to perform experimental somatic pain testing
to determine if there is evidence of peripherally-maintained central sensitization in
children with FAP. The investigators also hypothesize that there will be an increase in
somatic pain threshold after completion of a Cyproheptadine course compared to baseline
testing prior to treatment, and compared to placebo. This would allow children with FAP to
return to normal function, improve symptoms and overall general well-being
trial would help relieve abdominal pain associated with FAP in children, achieving a greater
response than that observed with placebo. In addition to assessing self-report of pain and
other symptoms, the investigators also propose to perform experimental somatic pain testing
to determine if there is evidence of peripherally-maintained central sensitization in
children with FAP. The investigators also hypothesize that there will be an increase in
somatic pain threshold after completion of a Cyproheptadine course compared to baseline
testing prior to treatment, and compared to placebo. This would allow children with FAP to
return to normal function, improve symptoms and overall general well-being
Inclusion Criteria:
- Age between 8 and 18 years-old
- Diagnosed with Functional Abdominal Pain using the Rome III Criteria must include
all* of the following:
1. Episodic or continuous abdominal pain
2. Insufficient criteria for other FGIDs
3. No evidence of an inflammatory, anatomic, metabolic, or neoplastic process that
explains the subject's symptoms
- Criteria fulfilled at least once per week for at least 2 months prior to
diagnosis
- Written informed consent obtained from the patient/guardian before the initiation of
any study-specific procedures
Exclusion Criteria:
- Age < 8 years-old or Age >18 years-old
- Child or parent are non-English speakers
- Child is using other CNS depressants (cyproheptadine causes drowsiness, and may
enhance the adverse/toxic effect of other CNS Depressants e.g. opioids, barbiturates,
Droperidol, Hydroxyzine, Alcohol)(29)
- Child has a history of hypersensitivity to Cyproheptadine products
- Child is currently using monoamine oxidase inhibitor (MAOI e.g. Nardil, Marplan,
Parnate) (can cause a prolonged or intensified anticholinergic effect)
- Child was treated with Cyproheptadine in the past 4 weeks
- Child is currently using anticholinergic (can cause an additive anticholinergic
effect e.g. Pramlintide)
- Concomitant SSRI use ( being a serotonin antagonist, may oppose effects)
- Concomitant use of Betahistine: Antihistamines may diminish the therapeutic effect of
Betahistine
- Concomitant use of Acetylcholinesterase Inhibitors (Central): Anticholinergics may
diminish the therapeutic effect of Acetylcholinesterase Inhibitors (Central) and vice
versa.
- Child has a personal history of glaucoma
- Child has asthma (can cause thickening of bronchial secretions) (27,28)
- History of liver dysfunction/disease (can cause hepatitis)
- History of cardiac disease (not specific to Cyproheptadine, antihistamines have been
associated with hypotension, palpitations, tachycardia and arrhythmias) (28,29).
- Females who are known to be pregnant will also be excluded. All females who are of
child bearing age, or are already menstruating will perform a urine pregnancy test
before enrolling.
- Any children who have difficulties swallowing tablets will receive teaching on how to
swallow tablets. If they are still unable to do so, they will not participate in the
study.
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