Methylnaltrexone Use for Opioid-induced Postoperative Constipation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Constipation in Pediatric Cancer Patients Receiving Vinca Alkaloids or Narcotics

NCT00032682

Constipation Neoplasms

COMPLETED

Development of an Instrument to Measure Quality of Life in Children With Chronic Constipation and Soiling

NCT00677508

Constipation Fecal Incontinence

COMPLETED

Osteopathic Manipulative Treatment for Constipation in People With Rett Syndrome

NCT05687214

Rett Syndrome

COMPLETED NA

Adherence and Outcomes in Functional Constipation With a Constipation Action Plan

NCT04614935

Adherence, Medication Functional Constipation Pediatric ALL +1 more

COMPLETED NA

Recurrent Abdominal Pain in Children

NCT00526903

Abdominal Pain Irritable Bowel Syndrome

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Constipation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Study group

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.

Group Type EXPERIMENTAL

Methylnaltrexone

Intervention Type DRUG

Patient will receive methylnaltrexone on postoperative day 3 on a weight based dose and again 24 hours later if required.

Senna, docusate sodium, bisacodyl, magnesium hydroxide, Miralax

Intervention Type 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.

Institutional bowel protocol

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.

Group Type ACTIVE_COMPARATOR

Senna, docusate sodium, bisacodyl, magnesium hydroxide, Miralax

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Methylnaltrexone

Patient will receive methylnaltrexone on postoperative day 3 on a weight based dose and again 24 hours later if required.

Intervention Type DRUG

Senna, docusate sodium, bisacodyl, magnesium hydroxide, Miralax

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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Relistor Senokot,Colace, Dulcolax, Milk of Magnesia, polyethylene glycol

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

12 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No