Methylnaltrexone Use for Opioid-induced Postoperative Constipation

Shriners Hospitals for Children

Status and phase: Completed; Phase 4

Conditions: Constipation

Treatments: Drug: Senna, docusate sodium, bisacodyl, magnesium hydroxide, Miralax; Drug: Methylnaltrexone

Study type: Interventional

Funder types: Other

Identifiers

NCT01773096

MNTX-2013

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 12 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Study group

Experimental group

Description:

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.

Treatment:

Drug: Methylnaltrexone

Drug: Senna, docusate sodium, bisacodyl, magnesium hydroxide, Miralax

Institutional bowel protocol

Active Comparator group

Description:

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.

Treatment:

Drug: Senna, docusate sodium, bisacodyl, magnesium hydroxide, Miralax