Pain Clinical Trial
Official title:
A Comparison of Postoperative Tramadol Versus Acetaminophen With Codeine in Children Undergoing Tonsillectomy
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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