None listed
Conditions
Brief 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.
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).
Sponsors
The Royal Children's Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to 18 Years
Healthy volunteers
No
Inclusion criteria
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 criteria
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
Outcome results
None listed