The Use of Methylnaltrexone to Reduce Post-operative Opioid-induced Constipation in the Pediatric Spinal Fusion Patient
| Registry | NCT01773096 |
|---|---|
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 60 (Estimated) |
| Sponsor | Shriners Hospitals for Children (Other) |
| Conditions | Constipation |
| Interventions | Methylnaltrexone, Senna, docusate sodium, bisacodyl, magnesium hydroxide, Miralax (Drug) |
| Dates | start 2013-05-01, primary completion 2015-05-01, completion 2015-05-01, first posted 2013-01-23, last updated 2015-05-19 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Constipation All trials of Methylnaltrexone All trials of Senna, docusate sodium, bisacodyl, magnesium hydroxide, Miralax
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Study group | Experimental | Drug: Methylnaltrexone; Drug: Senna, docusate sodium, bisacodyl, magnesium hydroxide, Miralax | 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. |
| Institutional bowel protocol | Active comparator | Drug: Senna, docusate sodium, bisacodyl, magnesium hydroxide, Miralax | 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. |
Sex: All, ages: 12 Years to 21 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Shriners Hospitals for Children- Spokane | Spokane, Washington | United States |