Pediatric Tonsillectomy Pain Reduction Study

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ClinicalTrials.gov Identifier: NCT00678379

Recruitment Status : Completed

First Posted : May 15, 2008

Results First Posted : July 2, 2017

Last Update Posted : July 2, 2017

Sponsor:

Information provided by (Responsible Party):

Jonathan R. Moss, Vanderbilt University Medical Center

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Postoperative Pain	Drug: lidocaine (1%) + bupivacaine (0.5%) Drug: Normal saline Drug: Lidocaine (1%) + Bupivacaine (0.5%) + Clonidine (25mcg)	Phase 3

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).

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	120 participants
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
Study Start Date :	April 2008
Actual Primary Completion Date :	November 2009
Actual Study Completion Date :	November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tonsillitis

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

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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)

Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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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

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United States, Tennessee
Vanderbilt University Monroe Carrel Jr. Children's Hospital
Nashville, Tennessee, United States, 37299

Sponsors and Collaborators

Vanderbilt University Medical Center

Investigators

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Principal Investigator:	Jonathan R Moss, MD, MPH	Vanderbilt University Medical Center

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):305-308. doi: 10.1016/0304-3959(91)90220-R.

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.

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. doi: 10.1001/archoto.2011.45. Epub 2011 Mar 21.

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Responsible Party:	Jonathan R. Moss, Resident Physician, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:	NCT00678379
Other Study ID Numbers:	080127
First Posted:	May 15, 2008 Key Record Dates
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:

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Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations Lidocaine Clonidine Bupivacaine Anesthetics, Local Anesthetics 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

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