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

March 11, 2014 updated by: Children's Hospitals and Clinics of Minnesota

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Children's Hospitals and Clinics of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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, aspartate aminotransferase [AST]/amino alanine transferase [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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Capital® with Codeine Suspension
Drug: Codeine with acetaminophen
Liquid codeine/acetaminophen (Capital® 5mL= 120mg acetaminophen/12 mg codeine) 0.72 mg/kg [=0.3 mL/kg] (max. 36 mg) PO Q6h, plus 0.72 mg/kg (max. 36 mg) PO Q3h pro re nata (PRN) (max. of 3 PRN doses/day)
Other Names:
  • Capital® with Codeine Suspension
  • Acetaminophen and Codeine phosphate suspension
Active Comparator: Tramadol suspension
Drug: Tramadol suspension
Liquid tramadol 1.05 mg/kg [=0.3 mL/kg] (max. 52.5 mg) PO Q6h, plus 1.05 mg/kg (max. 52.5 mg) PO Q3h PRN (max. of 3 PRN doses/day).
Other Names:
  • Ultram
  • tramadol hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of Two Different Liquid Pain Medications: Tramadol vs. Codeine/Acetaminophen During the Post-tonsillectomy Recovery Period.
Time Frame: Efficacy was assessed daily during the 10-day postoperative recovery period.
Average number of post-operative days with pain score >4/10. Pain score assessments were administered once daily by parents using either the Numeric Rating Scale (NRS-11) (with anchors 0=no pain and 10=highest pain imaginable) for children ages 8-15 (von Baeyer et al., 2009) or the Faces Pain Scale-Revised (FPS-R) (with anchors 0=no pain and 10=highest pain imaginable) for children ages 4-10 (Hicks et al., 2001).
Efficacy was assessed daily during the 10-day postoperative recovery period.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Reporting Side Effects During the Post-tonsillectomy Recovery Period.
Time Frame: Side effects will be observed and recorded daily by caregivers for a total of 10 days in the take-home diary.
Parent-reported side effects entered in 10-day diary.
Side effects will be observed and recorded daily by caregivers for a total of 10 days in the take-home diary.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospitals and Clinics of Minnesota

Investigators

  • Principal Investigator: Stefan J Friedrichsdorf, M.D., Children's Hospitals and Clinics of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

December 23, 2010

First Submitted That Met QC Criteria

December 23, 2010

First Posted (Estimate)

December 28, 2010

Study Record Updates

Last Update Posted (Estimate)

April 17, 2014

Last Update Submitted That Met QC Criteria

March 11, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1010-086

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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