Effect of Methylnaltrexone (Relistor) on Digestion and Tolerance to Tube Feeding in Patients Treated With Opiates

Study Overview
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Brief Summary
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It is hypothesized that using methylnaltrexone in addition to pain killer narcotics (opiates) in patients will result in increased tube feeding rates with more frequent nutrition at goal calorie rate.

Detailed Description
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Tube feeding rates and tube feeding residual volumes will be measured and followed blinded to the treatment arm (methylnaltrexone vs. placebo) to evaluate if patients (who prior to study entry did not tolerate goal rates tube feeds) can get closer to tube feeding goal with the treatment arm.

Official Title
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The Effect Of Methylnaltrexone (Relistor™) on Gut Motility and Tolerance to Tube Feeding in Patients Treated With Opiate Therapy

Conditions
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Tube Feeding

Intervention / Treatment
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* Drug: Methylnaltrexone
* Drug: Saline injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inadequate tube feeding rate of greater than equal to 40% below goal rate. Prescribed opiate therapy for pain or sedation, stable dose for minimum 48 hours Stable dose or no dose laxative for minimum 72 hours Exclusion Criteria: Unstable Hemodynamics (eg. vasopressor medication) Pregnancy End stage Renal Disease on Dialysis Plan to wean opiates in next 48 hours Known or suspected mechanical gastrointestinal obstruction Initial expired hydrogen breath level greater than 20

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Methylnaltrexone<br> | Drug: Methylnaltrexone<br>* Methylnaltrexone 8 mg IV for subjects 38 to 62 kg body weight, Methylnaltrexone12 mg IV for subjects 62.1 to 114 kg body weight<br>|
| Placebo Comparator: saline placebo injection<br> | Drug: Saline injection<br>* Saline 0.4 to 0.8 ml injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hydrogen breath test measure of bowel transit | On day 1 Hydrogen Breath Test (HBT) measures will occur 30 minutes before test meal, immediately after test meal every 15 minutes until a rise of 5ppm is detected or until 4 hours have passed. On day 2 Hydrogen Breath test measures will occur 30 minutes before test meal, immediately after test meal and every 15 minutes until a rise of 5ppm is detected or until 4 hours have passed. | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric residual volume measurement | Gastric residual volumes will be measured at baseline study entry and then every 4 hours throughout the study until 24 hours post study drug administration. | 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hydrogen breath test value and gastric residual volume measurements, Tube feeding tolerance while taking a stable dose of opiate