Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Pediatric Tonsillectomy Pain Reduction Study
This study is currently recruiting participants.
Verified by Vanderbilt University, December 2008
Sponsored by: Vanderbilt University
Information provided by: Vanderbilt University
ClinicalTrials.gov Identifier: NCT00678379
  Purpose

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).


Condition Intervention Phase
Postoperative Pain
Drug: lidocaine + bupivacaine
Drug: normal saline
Drug: lidocaine + bupivacaine + clonidine
Phase III

MedlinePlus related topics: Anesthesia Tonsils and Adenoids
Drug Information available for: Sodium chloride Clonidine Lidocaine Clonidine hydrochloride Bupivacaine Bupivacaine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Pediatric Tonsillectomy Pain Reduction Study, a Randomized, Placebo Controlled, Double-Blind Clinical Trial Using Clonidine and Local Anesthetics

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Total number of post-operative doses of analgesics. [ Time Frame: Post-operative days 1,3,5 & 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean number of pain medication doses per day. [ Time Frame: in recovery room; post-operative days 1,3,5 & 7 ] [ Designated as safety issue: No ]
  • Total time until discharge from hospital. [ Time Frame: Day of Surgery ] [ Designated as safety issue: No ]
  • Mean visual analog scale pain number. [ Time Frame: in recovery room; post-operative days 1,3,5 & 7 ] [ Designated as safety issue: No ]
  • Type of diet patient is able to tolerate. [ Time Frame: post-opeartive days 1,3,5 & 7. ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: April 2008
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Placebo Comparator
Normal Saline
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

B: Active Comparator
Lidocaine (1%) + Bupivacaine 0.5%
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%)

C: Experimental
Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg
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)


  Eligibility

Ages Eligible for Study:   3 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00678379

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

Locations
United States, Tennessee
Vanderbilt University Monroe Carrel Jr. Children's Hospital Recruiting
Nashville, Tennessee, United States, 37299
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Jonathan R Moss, MD, MPH Vanderbilt University
  More Information

Publications:
Responsible Party: Vanderbilt University Medical Center ( Jonathan R. Moss, MD MPH )
Study ID Numbers: 080127
Study First Received: May 8, 2008
Last Updated: December 12, 2008
ClinicalTrials.gov Identifier: NCT00678379  
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanderbilt University:
Tonsillectomy
Postoperative Pain
Clonidine
Anesthetics, Local

Study placed in the following topic categories:
Signs and Symptoms
Postoperative Complications
Clonidine
Lidocaine
Bupivacaine
Pain
Pain, Postoperative

Additional relevant MeSH terms:
Sympatholytics
Neurotransmitter Agents
Adrenergic alpha-Agonists
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Cardiovascular Agents
Antihypertensive Agents
Anesthetics, Local
Pharmacologic Actions
Adrenergic Agonists
Pathologic Processes
Autonomic Agents
Sensory System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009