Phase 4
N=84
A Comparison of Postoperative Tramadol Versus Acetaminophen With Codeine in Children Undergoing Tonsillectomy
Tonsillitis · Pain
Bottom Line
View on ClinicalTrials.gov: NCT01267136 ↗Enrolled (actual)
84
Serious AEs
2.4%
Results posted
Apr 2014
Primary outcome: Primary: Efficacy of Two Different Liquid Pain Medications: Tramadol vs. Codeine/Acetaminophen During the Post-tonsillectomy Recovery Period. — 1.5; 1 days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Codeine with acetaminophen (Drug); Tramadol suspension (Drug)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- Children's Hospitals and Clinics of Minnesota
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy of Two Different Liquid Pain Medications: Tramadol vs. Codeine/Acetaminophen During the Post-tonsillectomy Recovery Period. |
1.5; 1 | — |
| SECONDARY Number of Participants Reporting Side Effects During the Post-tonsillectomy Recovery Period. |
20; 20; 21; 18; 11; 10 | — |
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.
Eligibility 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, 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.
Data sourced from ClinicalTrials.gov (NCT01267136). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.