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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | 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 | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylnaltrexone | Drug | Patient will receive methylnaltrexone on postoperative day 3 on a weight based dose and again 24 hours later if required. |
|
| Measure | Description | Time Frame |
|---|---|---|
| reduction of post-operative opioid induced constipation | first post-operative week |
| Measure | Description | Time Frame |
|---|---|---|
| time to ambulation in post-operative pediatric spinal fusion patients | first post-operative week |
| Measure | Description | Time Frame |
|---|---|---|
| time to oral intake of pediatric post-operative spinal fusion patient | first post-operative week |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deborah J. Vermaire, M.D. | Shriners Hospitals for Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shriners Hospitals for Children- Spokane | Spokane | Washington | 99203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21998076 | Result | Anissian L, Schwartz HW, Vincent K, Vincent HK, Carpenito J, Stambler N, Ramakrishna T. Subcutaneous methylnaltrexone for treatment of acute opioid-induced constipation: phase 2 study in rehabilitation after orthopedic surgery. J Hosp Med. 2012 Feb;7(2):67-72. doi: 10.1002/jhm.943. Epub 2011 Oct 13. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 17, 2016 | |
| Reset | Oct 7, 2016 | |
| Release | Oct 12, 2016 | |
| Reset | Dec 2, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 17, 2016 | Oct 7, 2016 | |||
| Oct 12, 2016 |
| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C032257 | methylnaltrexone |
| D000081226 | Sennosides |
| D004143 | Dioctyl Sulfosuccinic Acid |
| D001726 | Bisacodyl |
| D008276 | Magnesium Hydroxide |
| C000595212 | polyethylene glycol 3350 |
| D011092 | Polyethylene Glycols |
| ID | Term |
|---|---|
| D012676 | Senna Extract |
| D000880 | Anthraquinones |
| D000095322 | Anthrones |
| D000873 | Anthracenes |
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| Senna, docusate sodium, bisacodyl, magnesium hydroxide, Miralax | Drug | 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. |
|
|
| Dec 2, 2016 |
| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011809 | Quinones |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D013386 | Succinates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003408 | Cresols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D017616 | Magnesium Compounds |
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |