Post-operative Pain Control After Pediatric Adenotonsillectomy

NCT02296840 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: IRB00070851
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Tonsillitis; Obstructive Sleep Apnea; Sleep Disordered Breathing; Adverse Reaction to Drug

Keywords

analgesia; non-steroidal anti-inflammatory drugs; narcotic-containing pain medication

Outcome Measures

Primary Outcomes (1)

• Faces Pain Score

  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.

  2 weeks after surgery

Secondary Outcomes (1)

• Number of Participants With Post-operative Bleeding

  2 weeks after surgery

Study Arms (2)

Ibuprofen

EXPERIMENTAL

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

Hydrocodone-acetaminophen (Control)

ACTIVE COMPARATOR

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

Interventions

Ibuprofen DRUG

Ibuprofen 10mg/kg/day every 6-8 hours

Also known as: Advil, Motrin

Ibuprofen

Hydrocodone-Acetaminophen DRUG

Hydrocodone-Acetaminophen 0.15mg/kg/day every 4-6 hours

Also known as: Vicodin, Lortab

Hydrocodone-acetaminophen (Control)

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ≥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

You may not qualify if:

• \<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)

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Children's Healthcare of Atlanta (CHOA)

Atlanta, Georgia, 30329, United States

Location

Related Publications (7)

• Randel A. AAO-HNS Guidelines for Tonsillectomy in Children and Adolescents. Am Fam Physician. 2011 Sep 1;84(5):566-73. No abstract available.

  PMID: 21888309 BACKGROUND

• Marret E, Flahault A, Samama CM, Bonnet F. Effects of postoperative, nonsteroidal, antiinflammatory drugs on bleeding risk after tonsillectomy: meta-analysis of randomized, controlled trials. Anesthesiology. 2003 Jun;98(6):1497-502. doi: 10.1097/00000542-200306000-00030. No abstract available.

  PMID: 12766664 BACKGROUND

• Lewis SR, Nicholson A, Cardwell ME, Siviter G, Smith AF. Nonsteroidal anti-inflammatory drugs and perioperative bleeding in paediatric tonsillectomy. Cochrane Database Syst Rev. 2013 Jul 18;2013(7):CD003591. doi: 10.1002/14651858.CD003591.pub3.

  PMID: 23881651 BACKGROUND

• St Charles CS, Matt BH, Hamilton MM, Katz BP. A comparison of ibuprofen versus acetaminophen with codeine in the young tonsillectomy patient. Otolaryngol Head Neck Surg. 1997 Jul;117(1):76-82. doi: 10.1016/S0194-59989770211-0.

  PMID: 9230328 BACKGROUND

• Mitchell RB, Kelly J. Behavior, neurocognition and quality-of-life in children with sleep-disordered breathing. Int J Pediatr Otorhinolaryngol. 2006 Mar;70(3):395-406. doi: 10.1016/j.ijporl.2005.10.020.

  PMID: 16321451 BACKGROUND

• Hicks CL, von Baeyer CL, Spafford PA, van Korlaar I, Goodenough B. The Faces Pain Scale-Revised: toward a common metric in pediatric pain measurement. Pain. 2001 Aug;93(2):173-183. doi: 10.1016/S0304-3959(01)00314-1.

  PMID: 11427329 BACKGROUND

• Hong SM, Cho JG, Chae SW, Lee HM, Woo JS. Coblation vs. Electrocautery Tonsillectomy: A Prospective Randomized Study Comparing Clinical Outcomes in Adolescents and Adults. Clin Exp Otorhinolaryngol. 2013 Jun;6(2):90-3. doi: 10.3342/ceo.2013.6.2.90. Epub 2013 Jun 14.

  PMID: 23799166 BACKGROUND

MeSH Terms

Conditions

Tonsillitis; Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Drug-Related Side Effects and Adverse Reactions; Agnosia

Interventions

Ibuprofen; oxycodone-acetaminophen; acetaminophen, hydrocodone drug combination

Condition Hierarchy (Ancestors)

Pharyngitis; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Chemically-Induced Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Limitations and Caveats

Many participants did not completed the pain control survey, limiting the conclusions that can be made from this study.

Results Point of Contact

• Title: Roy Rajan, MD
• Organization: Emory University

royrajan@yahoo.com

404-778-2400

Study Officials

• Roy Rajan, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 18, 2014
• First Posted: November 20, 2014
• Study Start: November 1, 2014
• Primary Completion: November 30, 2016
• Study Completion: November 30, 2016
• Last Updated: April 25, 2018
• Results First Posted: March 27, 2018

Record last verified: 2018-03

Locations

US (1)