Multicenter Perioperative Opioid Pharmacogenetic Study

NCT01495611 | Completed DMC

• 1 other identifier: 2010-1353
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 15

Brief Summary

The purpose of this research study is to identify factors and genes (the DNA material that determines the makeup of the human body) that may be associated with how children respond to pain medication. Specifically, the investigators want to study factors that may be associated with pain sensitivity, morphine requirement after surgery and side-effects from morphine and other pain medications. The investigators expect that the information obtained in this research study will help us to develop more effective, safe, and tailored treatment options in the future.

Conditions

Pain

Keywords

postoperative,; pediatric; pharmacogenetic; opioid; morphine; perioperative; respiratory depression

Outcome Measures

Primary Outcomes (1)

• Safety Outcomes

  Incidence of serious opioid related adverse effects including respiratory depression, excessive sedation, nausea and vomiting in recovery room.

  Post-anesthetic recovery room, an expected average of 2 hours

Secondary Outcomes (3)

• Efficacy Outcome Measures - Opioid interventions

  Post-anesthetic recovery room, an expected average of 2 hours

• Efficacy Outcome Measures - Opioid requirement

  Post-anesthetic recovery room, an expected average of 2 hours

• Efficacy Outcome Measures - Pain Scores

  Post-anesthetic recovery room, an expected average of 2 hours

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children undergoing adenotonsillectomy in the United States.

You may qualify if:

• children 6-17 years of age
• ASA physical status 1 and 2
• scheduled for tonsillectomy (T) and tonsillectomy and adenoidectomy (T and A)
• Children with obstructive sleep apnea will also be included.

You may not qualify if:

• children with developmental delay
• liver and renal diseases,
• preoperative pain requiring analgesics (e.g. chronic tonsillitis).

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Baylor College of Medicine: collaborator
• Ochsner Health System: collaborator
• Children's Hospital Colorado: collaborator
• Children's Hospital Los Angeles: collaborator
• C.S. Mott Children's Hospital: collaborator
• St. Christopher's Hospital for Children: collaborator
• St. Louis Children's Hospital: collaborator
• Boston Children's Hospital: collaborator
• Seattle Children's Hospital: collaborator
• Ann & Robert H Lurie Children's Hospital of Chicago: collaborator
• University of Wisconsin, Madison: collaborator
• University of Miami: collaborator
• Johns Hopkins University: collaborator
• Stanford University: collaborator
• Phoenix Children's Hospital: collaborator
• University of Michigan: collaborator
• University of Utah: collaborator
• Shanghai Children's Hospital: collaborator

Study Sites (15)

Children's Hospital of Los Angeles

Los Angeles, California, 90027, United States

Location

Stanford University Medical Center

Palo Alto, California, 94304, United States

Location

The Children's Hospital, Denver

Denver, Colorado, 80045, United States

Location

University of Miami - Miller School of Medicine

Miami, Florida, 33136, United States

Location

Children's Memorial Hospital

Chicago, Illinois, 60614, United States

Location

Ochsner Medical Center for Children

New Orleans, Louisiana, 70121, United States

Location

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

C.S. Mott Children's Hospital

Ann Arbor, Michigan, 48109, United States

Location

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

St. Christopher's Hospital for Children

Philadelphia, Pennsylvania, 19134, United States

Location

Texas Children's Hospital

Houston, Texas, 77094, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

UW Health-American Family Children's Hospital

Madison, Wisconsin, 53792, United States

Location

Related Publications (41)

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Biospecimen

Retention: SAMPLES WITH DNA

A database/ repository will be constructed for future research, analysis, and recruitment. De-identified study subjects' genetic information and their responses to pain and pain medications, side-effects will be included in the database. Blood specimens will be included in the repository for exploring potentially important SNPs and biomarkers in future. No patient identifiers will be included in the repository and there will be a confidential (access limited to investigators only) code or link between the repository/database and other information about the participant.

MeSH Terms

Conditions

Pain; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Senthilkumar Sadhasivam

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2011
• First Posted: December 20, 2011
• Study Start: November 1, 2010
• Primary Completion: January 1, 2016
• Study Completion: April 30, 2017
• Last Updated: January 31, 2017

Record last verified: 2017-01

Locations

US (15)