Post-operative Pain Control After Pediatric Adenotonsillectomy
Condition: Recurrent Tonsillitis; Obstructive Sleep Apnea; Sleep Disordered Breathing; Adverse Reaction to Drug
MeSH terms: Tonsillitis; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Drug-Related Side Effects and Adverse Reactions
Intervention: Ibuprofen; Hydrocodone-Acetaminophen
Intervention description: Ibuprofen 10mg/kg/day every 6-8 hours; Hydrocodone-Acetaminophen 0.15mg/kg/day every 4-6 hours
Intervention MeSH terms: Acetaminophen; Ibuprofen; Acetaminophen, hydrocodone drug combination; Hydrocodone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 45.0
Sex: All
Minimum age: 4 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: analgesia; non-steroidal anti-inflammatory drugs; narcotic-containing pain medication

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.
    

Eligibility 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)