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Pediatric Tonsillectomy Pain Reduction Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00678379
First Posted: May 15, 2008
Last Update Posted: July 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jonathan R. Moss, Vanderbilt University Medical Center
  Purpose
Tonsillectomy is associated with a significant decrease quality of life in children secondary to pain, which is worsened with swallowing. 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 (1%) + bupivacaine (0.5%) Drug: Normal saline Drug: Lidocaine (1%) + Bupivacaine (0.5%) + Clonidine (25mcg) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Jonathan R. Moss, Vanderbilt University Medical Center:

Primary Outcome Measures:
  • Total Number of Post-operative Doses of Analgesics. [ Time Frame: Post-operative thru day 7 ]
    The total number of intravenous fentanyl doses given PACU which will be compared between the three randomized groups (arms)


Secondary Outcome Measures:
  • Median Number of Pain Medication Doses [ Time Frame: in recovery room ]
    The median number of intravenous fentanyl doses administered in the PACU due to pain

  • Total Time Until Discharge From Hospital. [ Time Frame: Day of Surgery ]
  • Mean Visual Analog Scale Pain Number. [ Time Frame: in recovery room; post-operative days 1,3,5 & 7 ]
    Visual analog pain scale range is 0-10 with 0=no pain and 10 = worst pain ever

  • Number and Percent of Participants Able to Tolerate Only Liquids [ Time Frame: post-operative days 1,3,5 & 7. ]
    The number and percent of patients whose post-operative diet has advanced to liquids only on post-op days 1, 3, 5 & 7

  • Number and Percent of Participants Able to Tolerate Only a Soft Diet [ Time Frame: post-operative days 1,3,5 & 7. ]
    The number and percent of patients whose post-operative diet has only advanced to a soft diet on post-operative days 1, 3, 5 & 7

  • Number and Percent of Participants Able to Tolerate a Regular Diet [ Time Frame: post-operative days 1,3,5 & 7. ]
    The number and percent of patients whose post-operative diet has to a regular diet on post-operative days 1, 3, 5 & 7


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: Normal Saline
1.5 ml injection of Normal Saline into each tonsillar fossa pre-tonsillectomy
Drug: Normal saline

Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy.

A - normal saline

Active Comparator: Lidocaine (1%) + Bupivacaine 0.5%
Submucosal injection of 1.5 mL Lidocaine (1%) + Bupivacaine 0.5% into the tonsillar fossa, pre-tonsillectomy
Drug: lidocaine (1%) + bupivacaine (0.5%)

Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy.

B - lidocaine (1%) + bupivacaine (0.5%)

Experimental: Lidocaine + Bupivacaine + Clondine
Submucosal injection of 1.5 mL Lidocaine 1% + Bupivacaine 0.5% + Clondine 25mcg into the tonsillar fossa, pre-tonsillectomy
Drug: Lidocaine (1%) + Bupivacaine (0.5%) + Clonidine (25mcg)

Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy.

C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)


Detailed Description:
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).
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00678379


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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jonathan R. Moss, Resident Physician, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00678379     History of Changes
Other Study ID Numbers: 080127
First Submitted: May 8, 2008
First Posted: May 15, 2008
Results First Submitted: May 1, 2017
Results First Posted: July 2, 2017
Last Update Posted: July 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: No plan to share unless specifically requested within 5 year storage of data period.

Keywords provided by Jonathan R. Moss, Vanderbilt University Medical Center:
Tonsillectomy
Postoperative Pain
Clonidine
Anesthetics, Local

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Lidocaine
Bupivacaine
Anesthetics
Clonidine
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents