An open-label, pilot study to examine the pharmacokinetics, efficacy and safety of Methylnaltrexone Bromide in paediatric patients with opioid-induced constipation who have failed standard aperient treatment.
The Royal Children's Hospital
6 participants
Apr 1, 2011
Interventional
Conditions
Summary
The use of Methylnaltrexone Bromide is approved to treat adults with opioid-induced constipation, but it has not yet been test in children with opioid-induced constipation. This study will see how safe and effective Methylnaltrexone Bromide is in children with opioid-induced constipation.
Eligibility
Inclusion Criteria5
- An inpatient at the Royal Children's Hospital
- Diagnosis of constipation as defined by lack of bowel motion for 3 days
- Chronic opioid treatment (1 week continuous duration)
- Failed all other standard aperient treatment
- Vascular access
Exclusion Criteria4
- Other causes of constipation (eg cow's milk protein intolerance, poor oral intake)
- Signs and symptoms of bowel obstruction
- Suspected or diagnosed with delirium
- Likely to pass away this admission
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Interventions
A single subcutaneous injection of Methylnaltrexone Bromide (0.15mg/kg) at baseline. If the injection has not been effective within 24 hours (ie no bowel action), the injection may be repeated (but the pharmacokinetic samples will not be repeated).
Locations(1)
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ACTRN12611000002987