Post-operative Pain Control After Pediatric Adenotonsillectomy
Status:
Terminated
Trial end date:
2016-11-30
Target enrollment:
Participant gender:
Summary
Adenotonsillectomy is one of the most common surgical procedures performed in the pediatric
population in the United States. It is generally a well-tolerated procedure with
post-operative bleeding risk ranging from 3-5% in children. Post-operative pain following
adenotonsillectomy has significant morbidity and may result in prolonged hospital stay or
re-admission to the hospital. Post-operative analgesia is most commonly managed with
narcotic-containing pain medication. In recent years however, there is evidence that some
patients may manifest increased sensitivity to narcotics, resulting in life-threatening
respiratory compromise. Though there is a theoretical risk that nonsteroidal
anti-inflammatory drugs (NSAIDs) increase bleeding time by disrupting platelet aggregation,
evidence of detrimental effects (i.e. increased risk of postoperative bleeding) remains
inconclusive for these generally well-tolerated medications. The goal of this study is to
determine the incidence of post-operative bleeding and to determine the efficacy of NSAIDs in
the management of post-operative pain following pediatric adenotonsillectomy, versus more
commonly used narcotic pain medication. The study design will be an initial retrospective
study to collect pilot data on the incidence of postoperative hemorrhage and indicators of
adequate/inadequate pain control in children age 4 to 17 undergoing adenotonsillectomy. This
will be followed by a prospective, randomized, single-blind controlled study in which
orally-administered ibuprofen (test intervention) is compared to acetaminophen-hydrocodone
(control intervention) in the postoperative period following adenotonsillectomy.