Methylnaltrexone Use for Opioid-induced Postoperative Constipation

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the routine use of methylnaltrexone in the post-operative pediatric spinal fusion patient will decrease the incidence of constipation.

Detailed Description
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Methylnaltrexone will be given to pediatric patients post-operative from spinal fusion surgery on post-operative day number 3 and then again on postoperative day number 4, if no laxation achieved. Various outcome measures, safety and efficacy of the drug will be observed and recorded.

Official Title
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The Use of Methylnaltrexone to Reduce Post-operative Opioid-induced Constipation in the Pediatric Spinal Fusion Patient

Conditions
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Constipation

Intervention / Treatment
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* Drug: Methylnaltrexone
* Drug: Senna, docusate sodium, bisacodyl, magnesium hydroxide, Miralax


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: spinal fusion surgery current opioid use 12 years of age and older no or inadequate bowel movement by post-operative day 3 Exclusion Criteria: known or expected mechanical bowel obstruction known or suspected lesions of the GI tract unexpected transfer to ICU unexpected return to the operating room patient or parent refusal of methylnaltrexone incomplete data concerning time to laxation

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 21 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Weight-based dose (0.15 mg/kg for patients less than 38 kg, 8 mg for patients weighing 38-62 kg, or 12 mg for patients weighing greater than 62 kg) of methylnaltrexone will be administered on post-operative day 3 and again, if indicated, on post-operative day 4. This group will also receive the standard bowel protocol beginning on postoperative day one as per protocol. | Drug: Methylnaltrexone<br>* Patient will receive methylnaltrexone on postoperative day 3 on a weight based dose and again 24 hours later if required.<br>* Other names: Relistor;Drug: Senna, docusate sodium, bisacodyl, magnesium hydroxide, Miralax<br>* Standard institutional bowel protocol will begin on post-operative day 1. Miralax,Docusate sodium or senna will be given on a weight-based dosing. If no bowel movement in 72 hours, bisacodyl or magnesium hydroxide will be added.<br>* Other names: Senokot,Colace, Dulcolax, Milk of Magnesia, polyethylene glycol;|
| Active Comparator: Institutional bowel protocol<br>Patient will receive institutional standard bowel protocol. Beginning on post-operative day one either miralx,docusate sodium or senna, on a weight-based dose. If no bowel movement in 72 hours, either oral bisacodyl or magnesium hydroxide, on a weight-based dosing, will be added. | Drug: Senna, docusate sodium, bisacodyl, magnesium hydroxide, Miralax<br>* Standard institutional bowel protocol will begin on post-operative day 1. Miralax,Docusate sodium or senna will be given on a weight-based dosing. If no bowel movement in 72 hours, bisacodyl or magnesium hydroxide will be added.<br>* Other names: Senokot,Colace, Dulcolax, Milk of Magnesia, polyethylene glycol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction of post-operative opioid induced constipation |  | first post-operative week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to ambulation in post-operative pediatric spinal fusion patients |  | first post-operative week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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opioid-induced