Trial record 11 of 96 for:    tonsillectomy

Pediatric Tonsillectomy Pain Reduction Study

This study has been completed.
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00678379
First received: May 8, 2008
Last updated: December 10, 2009
Last verified: December 2009
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pediatric Tonsillectomy Pain Reduction Study, a Randomized, Placebo Controlled, Double-Blind Clinical Trial Using Clonidine and Local Anesthetics

Resource links provided by NLM:


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
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A
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

Active Comparator: B
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%)

Other Name: Duraclon
Experimental: C
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jonathan R. Moss, MD MPH, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00678379     History of Changes
Other Study ID Numbers: 080127
Study First Received: May 8, 2008
Last Updated: December 10, 2009
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Anesthetics, Local
Bupivacaine
Lidocaine
Anesthetics
Clonidine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antihypertensive Agents
Cardiovascular Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on July 24, 2014