Official Title: “Pediatric Tonsillectomy Pain Reduction Study, a Randomized, Placebo Controlled, Double-Blind Clinical Trial Using Clonidine and Local Anesthetics”

Tonsillectomy is associated with a significant decrease quality of life in children secondary to pain, which is worsened with swallowing. Previous studies in the pediatric population have demonstrated a significant decrease in post-operative pain/morbidity when administering pain reduction medications into the tonsillar fossa prior to removal. While these studies have shown great promise, no large randomized trial of the most promising medications has been conducted. Because of this, many otolaryngologists do not administer intra-operative medications aimed at reducing post-operative pain. The objective of the current study is to conduct a prospective, double-blind, placebo-controlled, randomized clinical trial using a pre-tonsillectomy infiltration of the tonsillar fossa comparing three treatment regimens in reducing post-tonsillectomy morbidity (i.e. pain, poor oral intake): 1) Placebo (saline injection) 2) bupivacaine (0.5%) + lidocaine (1%), 3) bupivacaine (0.5%) + lidocaine (1%) + clonidine (25 µg).

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: June 2009

Intervention(s) in this Clinical Trial

• Drug: lidocaine + bupivacaine
  • Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. B - lidocaine (1%) + bupivacaine (0.5%)
• Drug: normal saline
  • Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. A - normal saline
• Drug: lidocaine + bupivacaine + clonidine
  • Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: A
  • Normal Saline
• Active Comparator: B
  • Lidocaine (1%) + Bupivacaine 0.5%
• Experimental: C
  • Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg

Primary Measures

• Total number of post-operative doses of analgesics.
  • Time Frame: Post-operative days 1,3,5 & 7
    Safety Issue?: No

Secondary Measures

• Mean number of pain medication doses per day.
  • Time Frame: in recovery room; post-operative days 1,3,5 & 7
    Safety Issue?: No
• Total time until discharge from hospital.
  • Time Frame: Day of Surgery
    Safety Issue?: No
• Mean visual analog scale pain number.
  • Time Frame: in recovery room; post-operative days 1,3,5 & 7
    Safety Issue?: No
• Type of diet patient is able to tolerate.
  • Time Frame: post-opeartive days 1,3,5 & 7.
    Safety Issue?: No

Inclusion Criteria:

• Age 3 - 17 years old
• BMI < 35
• Negative pregnancy test in female patients age 10 and older
• Diagnosed with adenotonsillar hypertrophy, recurrent adenotonsillitis or upper airway obstruction and will be undergoing tonsillectomy alone or adenotonsillectomy

Exclusion Criteria:

• Diagnosis of obstructive sleep apnea
• Patient with peritonsillar abscess
• Allergy to study medication
• Any major systemic illness, genetic disorder or diagnosed syndrome
• Bleeding disorder

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 3 Years

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Vanderbilt University

Overall Clinical Trial Officials and Contacts

Jonathan R Moss, MD, MPH Principal Investigator Vanderbilt University  

Overall Contact: Jonathan R Moss, MD, MPH 615-300-2290 jonathan.moss@vanderbilt.edu

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00678379

Study ID Number: 080127

ClinicalTrials.gov Identifier: NCT00678379

Health Authority: United States: Food and Drug Administration