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.
Phase 4
- Conditions
- Opioid-induced ConstipationOral and Gastrointestinal - Normal oral and gastrointestinal development and function
- Registration Number
- ACTRN12611000002987
- Lead Sponsor
- The Royal Children's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 6
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method A pharmacokinetic profile of one dose of Methylnaltrexone Bromide in paediatric patients with opioid-induced constipation will be established from PK blood samples collected at 1, 2, 4, 8, 12 and 24 hours after the time of injection. The area under the curve will be calculated.[24 hour pharmacokinetic sampling period]
- Secondary Outcome Measures
Name Time Method The safety of Methylnaltrexone Bromide in a paediatric population with opioid induced constipation[Adverse reactions will be monitored and recorded at Time point 0hours, 1, 2, 4, 8, 12, 24 hours post injection and up to 1 week post injection.];The effectiveness of Methylnaltrexone Bromide in a paediatric population with opioid induced constipation will be assessed with the use of a bowel action diary. The log features the Bristol Stool Chart to assist with categorising stool type, as well as space for completing day, time, amount, strain, pain, tummy ache and rectal bleeding.[The bowel movement diary will be completed any time there is a bowel movement from the time of injection up to 1 week post injection.]