Methylnaltrexone Use for Opioid-induced Postoperative Constipation

S

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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