NCT01773096

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 23, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 19, 2015

Status Verified

May 1, 2015

Enrollment Period

2 years

First QC Date

January 15, 2013

Last Update Submit

May 15, 2015

Conditions

Constipation

Keywords

opioid-induced

Outcome Measures

Primary Outcomes (1)

  • reduction of post-operative opioid induced constipation

    first post-operative week

Secondary Outcomes (1)

  • time to ambulation in post-operative pediatric spinal fusion patients

    first post-operative week

Other Outcomes (1)

  • time to oral intake of pediatric post-operative spinal fusion patient

    first post-operative week

Study Arms (2)

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.

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

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.

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

Interventions

MethylnaltrexoneDRUG

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

Also known as: Relistor
Study group
Senna, docusate sodium, bisacodyl, magnesium hydroxide, MiralaxDRUG

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.

Also known as: Senokot,Colace, Dulcolax, Milk of Magnesia, polyethylene glycol
Institutional bowel protocolStudy group

Eligibility Criteria

Age12 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • spinal fusion surgery
  • current opioid use
  • years of age and older
  • no or inadequate bowel movement by post-operative day 3

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shriners Hospitals for Children- Spokane

Spokane, Washington, 99203, United States

Location

Related Publications (1)

  • 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.

    PMID: 21998076RESULT

MeSH Terms

Conditions

Constipation

Interventions

methylnaltrexoneSennosidesDioctyl Sulfosuccinic AcidBisacodylMagnesium Hydroxidepolyethylene glycol 3350Polyethylene Glycols

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Senna ExtractAnthraquinonesAnthronesAnthracenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsQuinonesPolycyclic CompoundsGlycosidesCarbohydratesPlant ExtractsPlant PreparationsBiological ProductsComplex MixturesSuccinatesDicarboxylic AcidsAcids, AcyclicCarboxylic AcidsCresolsPhenolsBenzene DerivativesHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesMagnesium CompoundsEthylene GlycolsGlycolsAlcoholsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Deborah J. Vermaire, M.D.

    Shriners Hospitals for Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

January 15, 2013

First Posted

January 23, 2013

Study Start

May 1, 2013

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

May 19, 2015

Record last verified: 2015-05

Locations

US(1)