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Post-operative Pain Control After Pediatric Adenotonsillectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02296840
Recruitment Status : Terminated
First Posted : November 20, 2014
Results First Posted : March 27, 2018
Last Update Posted : April 25, 2018
Information provided by (Responsible Party):
Roy Rajan, Emory University

Brief 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.

Condition or disease Intervention/treatment Phase
Recurrent Tonsillitis Obstructive Sleep Apnea Sleep Disordered Breathing Adverse Reaction to Drug Drug: Ibuprofen Drug: Hydrocodone-Acetaminophen Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Comparing Narcotics With Non-steroidal Anti-inflammatory Drugs (NSAIDS) Post-operatively in Pediatric Patients Undergoing Adenotonsillectomy
Actual Study Start Date : November 2014
Actual Primary Completion Date : November 30, 2016
Actual Study Completion Date : November 30, 2016

Arm Intervention/treatment
Experimental: Ibuprofen
After undergoing adenotonsillectomy, patients who are randomized into the test intervention arm will receive ibuprofen (10mg/kg/day every 6-8 hours) after surgery.
Drug: Ibuprofen
Ibuprofen 10mg/kg/day every 6-8 hours
Other Names:
  • Advil
  • Motrin

Active Comparator: Hydrocodone-acetaminophen (Control)
After undergoing adenotonsillectomy, patients who are randomized into the control intervention will receive hydrocodone-acetaminophen (0.15mg/kg/day every 4-6 hours).
Drug: Hydrocodone-Acetaminophen
Hydrocodone-Acetaminophen 0.15mg/kg/day every 4-6 hours
Other Names:
  • Vicodin
  • Lortab

Primary Outcome Measures :
  1. Faces Pain Score [ Time Frame: 2 weeks after surgery ]
    Using the Faces Pain Scale, the pediatric patient will indicate his/her pain level at scheduled intervals (7 times per day) for 14 days post-surgery.The Faces Pain Scale Revised is a dimensionless 10 point likert scale used to assess self-reported pain intensity on a scale from 0 (no pain) to 10 (most pain you can imagine). Greater pain scores are indicative of more severe pain. For this analysis, participant pain scores were summed and the mean per group was calculated. Total summed scores could range from 0 to 980.

Secondary Outcome Measures :
  1. Number of Participants With Post-operative Bleeding [ Time Frame: 2 weeks after surgery ]
    The occurrence of post-operative bleeding at the surgical site for each participant will be assessed by review of the participant's study records and clinical records and by questioning the caregiver in follow-up. If postoperative bleeding has occurred, details of the episode of bleeding will also be obtained (requirement for surgical intervention, observation at home, or observation at the hospital).

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Ages Eligible for Study:   4 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02296840

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United States, Georgia
Children's Healthcare of Atlanta (CHOA)
Atlanta, Georgia, United States, 30329
Sponsors and Collaborators
Emory University
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Principal Investigator: Roy Rajan, MD Emory University

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Responsible Party: Roy Rajan, Assistant Professor, Emory University Identifier: NCT02296840     History of Changes
Other Study ID Numbers: IRB00070851
First Posted: November 20, 2014    Key Record Dates
Results First Posted: March 27, 2018
Last Update Posted: April 25, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Roy Rajan, Emory University:
non-steroidal anti-inflammatory drugs
narcotic-containing pain medication
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Drug-Related Side Effects and Adverse Reactions
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Chemically-Induced Disorders
Anti-Inflammatory Agents, Non-Steroidal
Acetaminophen, hydrocodone drug combination
Anti-Inflammatory Agents
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs