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Pharmacogenomics Analysis of Morphine Pharmacokinetics in Pediatric Tonsillectomy and Adenoidectomy

NCT00836264 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 878

Last updated 2019-04-02

No results posted yet for this study

Summary

Intravenous (IV) morphine requirement for immediate postoperative pain control depends upon the complex interplay of patient history, wound severity, environment, and genetics. Even for relatively uniform stimulus intensity, such as that associated with tonsillectomy and adenoidectomy (T\&A), there can be marked individual variability in response to morphine. Some patients are refractory to standard doses and need increased amounts. Others are sensitive, require less drug to attain acceptable pain levels, and/or experience unwanted side effects that limit dosing. A significant number must be switched to different analgesics altogether. Despite the long clinical history of morphine as a postoperative analgesic, researchers have only begun to examine the origins of response variability.

The investigators will look at 2000 retrospective Tonsillectomy and Adenoidectomy (T\&A) cases and using this data and incorporating additional patient, surgical, and environmental factors that may contribute to response variability, the investigators then propose a prospective genome-wide association (GWA) study of 1500 children ages 4 to 18 years treated with IV morphine sulfate for day surgery T\&A.

Conditions

  • Tonsillectomy
  • Adenoidectomy
  • Pharmacokinetics

Sponsors & Collaborators

Principal Investigators

  • Scott Cook-Sather, MD · Children's Hospital of Philadelphia

Eligibility

Min Age
4 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00836264 on ClinicalTrials.gov