Pediatric Tonsillectomy Pain Reduction Study - Full Text View

Sponsor:	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 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:

MedlinePlus related topics: Tonsils and Adenoids

Drug Information available for: Lidocaine hydrochloride Lidocaine Clonidine Clonidine hydrochloride Bupivacaine hydrochloride Bupivacaine

U.S. FDA Resources

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

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:

Cucchiaro G, Ganesh A. The effects of clonidine on postoperative analgesia after peripheral nerve blockade in children. Anesth Analg. 2007 Mar;104(3):532-7.

Naja MZ, El-Rajab M, Kabalan W, Ziade MF, Al-Tannir MA. Pre-incisional infiltration for pediatric tonsillectomy: a randomized double-blind clinical trial. Int J Pediatr Otorhinolaryngol. 2005 Oct;69(10):1333-41. Epub 2005 Apr 22.

McCartney CJ, Duggan E, Apatu E. Should we add clonidine to local anesthetic for peripheral nerve blockade? A qualitative systematic review of the literature. Reg Anesth Pain Med. 2007 Jul-Aug;32(4):330-8. Review.

Jebeles JA, Reilly JS, Gutierrez JF, Bradley EL Jr, Kissin I. Tonsillectomy and adenoidectomy pain reduction by local bupivacaine infiltration in children. Int J Pediatr Otorhinolaryngol. 1993 Jan;25(1-3):149-54.

Jebeles JA, Reilly JS, Gutierrez JF, Bradley EL Jr, Kissin I. The effect of pre-incisional infiltration of tonsils with bupivacaine on the pain following tonsillectomy under general anesthesia. Pain. 1991 Dec;47(3):305-8.

Giannoni C, White S, Enneking FK, Morey T. Ropivacaine with or without clonidine improves pediatric tonsillectomy pain. Arch Otolaryngol Head Neck Surg. 2001 Oct;127(10):1265-70.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Moss JR, Cofer S, Hersey S, Goudy S, Werkhaven J, Swanson E, Mantle C, Stowell N, Byrne D, Wang L, Labadie R. Comparison of clonidine, local anesthetics, and placebo for pain reduction in pediatric tonsillectomy. Arch Otolaryngol Head Neck Surg. 2011 Jun;137(6):591-7. Epub 2011 Mar 21.

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 May 24, 2012