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A Comparison of Postoperative Tramadol Versus Acetaminophen With Codeine in Children Undergoing Tonsillectomy

Information source: Children's Hospitals and Clinics of Minnesota
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Tonsillitis; Pain

Intervention: Codeine with acetaminophen (Drug); Tramadol suspension (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Children's Hospitals and Clinics of Minnesota

Official(s) and/or principal investigator(s):
Stefan J Friedrichsdorf, M.D., Principal Investigator, Affiliation: Children's Hospitals and Clinics of Minnesota

Overall contact:
Stefan J Friedrichsdorf, M.D., Phone: 612-813-6498, Email: stefan.friedrichsdorf@childrensmn.org

Summary

Tonsillectomy is the most common pediatric surgical procedure performed in the US. The postoperative period can be particularly painful. Codeine (usually in mixed formulation with acetaminophen) is the most commonly prescribed opioid in the US. However, evolving data questions its ability to provide optimal pain relief, while avoiding side effects, especially in the postoperative setting. Tramadol may be a better option for children in the postoperative setting due to its well-documented analgesic properties, low potential for side effects, and excellent safety profile. Seventy-two children scheduled to undergo tonsillectomy (with or without adenoidectomy) at Children's will be invited to participate in a randomized, prospective, double-blinded study to evaluate the efficacy and side effects of codeine with acetaminophen versus tramadol. Using a 10-day take-home diary, caregivers will be asked to record daily information about their child's postoperative pain and other core outcomes and domains as recommended in the recent consensus statement put forth by the Pediatric Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) (McGrath et al., 2008). This study will offer new information regarding the efficacy and side effects associated with tramadol as compared with codeine/acetaminophen (the current practice standard) in a pediatric population.

Hypotheses

H1: Children who receive scheduled tramadol following tonsillectomy will report better pain control than children who receive scheduled codeine/acetaminophen.

H2: Children who receive scheduled tramadol following tonsillectomy will report fewer side effects than children who receive scheduled codeine/acetaminophen.

Clinical Details

Official title: A Comparison of Postoperative Tramadol Versus Acetaminophen With Codeine in Children Undergoing Tonsillectomy

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Compare the efficacy of two different liquid pain medications: tramadol vs. codeine/acetaminophen (the current standard) during the post-tonsillectomy recovery period.

Secondary outcome: Compare side effects of two different pain medications (tramadol vs. codeine/acetaminophen) during the post-tonsillectomy recovery period.

Eligibility

Minimum age: 4 Years. Maximum age: 15 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Child must be scheduled to undergo tonsillectomy (with or without adenoidectomy).

- Child must be between the ages of 4 and 15 at the time of enrollment.

- Child and caregiver must be English-speaking.

- The same caregiver (e. g., mother) must agree to complete all study assessments with

child to ensure consistency.

Exclusion Criteria:

- Child cannot self-assess pain due to conditions such as developmental delays,

chromosomal abnormalities, and other syndromes.

- Child had significant adverse effects to codeine, tramadol, or acetaminophen in the

past.

- Child has a known underlying seizure disorder (not febrile seizure).

- Child has known underlying renal or liver dysfunction (with creatinine, AST/ALT,

above normal value for age, respectively).

- Child or caregiver is not English-speaking.

- The same caregiver (e. g., mother) is unable to complete all follow-up assessments.

Locations and Contacts

Stefan J Friedrichsdorf, M.D., Phone: 612-813-6498, Email: stefan.friedrichsdorf@childrensmn.org

Children's Hospitals and Clinics of Minnesota, Minneapolis, Minnesota 55404, United States; Recruiting
Andrea C Nugent, MPH, Phone: 612-813-6409, Email: andrea.nugent@childrensmn.org
Stefan J Friedrichsdorf, M.D., Principal Investigator
James D Sidman, M.D., Sub-Investigator
Andrea C Nugent, M.P.H., Sub-Investigator
Meixia Liu, M.S., Sub-Investigator
Additional Information

Related publications:

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Starting date: January 2011
Last updated: September 26, 2011

Page last updated: December 08, 2011

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