Post-operative Pain Control After Pediatric Adenotonsillectomy

• Status: Terminated
• Trial end date: 2016-11-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Treatments: Acetaminophen; Acetaminophen, hydrocodone drug combination; Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Hydrocodone; Ibuprofen; Narcotics; Oxycodone

Criteria

Inclusion Criteria:

• ≥4 and ≤17 years old

• Meeting criteria for tonsillectomy based on AAO-HNS clinical guidelines:

Adenotonsillectomy is indicated for patients with recurrent adenotonsillitis and sleep disordered breathing. Both groups in this study will have surgery for the same preoperative indications

Exclusion Criteria:

• <4 or >17 years old

• Known bleeding diathesis (or family history of bleeding diathesis)

• Known allergy to any study medication

• participant/caregiver inability to understand or complete the required study documentation (pain scales, medication logs)