A Comparison of Postoperative Tramadol Versus Acetaminophen With Codeine in Children Undergoing Tonsillectomy
Information source: Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Tonsillitis; Pain
Intervention: Codeine with acetaminophen (Drug); Tramadol suspension (Drug)
Phase: Phase 4
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
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.
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.
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: Efficacy of Two Different Liquid Pain Medications: Tramadol vs. Codeine/Acetaminophen During the Post-tonsillectomy Recovery Period.
Secondary outcome: Number of Participants Reporting Side Effects During the Post-tonsillectomy Recovery Period.
Minimum age: 4 Years.
Maximum age: 15 Years.
- 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.
- 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
- 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,
- Child or caregiver is not English-speaking.
- The same caregiver (e. g., mother) is unable to complete all follow-up assessments.
Locations and Contacts
Children's Hospitals and Clinics of Minnesota, Minneapolis, Minnesota 55404, United States
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Starting date: January 2011
Last updated: March 11, 2014