Pediatric Tonsillectomy Pain Reduction Study

Postoperative Pain Clinical Trial

Official title:

Pediatric Tonsillectomy Pain Reduction Study, a Randomized, Placebo Controlled, Double-Blind Clinical Trial Using Clonidine and Local Anesthetics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00678379
• Other study ID #: 080127
• Status: Completed
• Phase: Phase 3
• First received: May 8, 2008
• Last updated: December 10, 2009
• Start date: April 2008
• Est. completion date: November 2009

Study information

• Verified date: December 2009
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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%)
• normal saline
Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. A - normal saline
• 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)

Locations

Country	Name	City	State
United States	Vanderbilt University Monroe Carrel Jr. Children's Hospital	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total number of post-operative doses of analgesics.		Post-operative days 1,3,5 & 7	No
Secondary	Mean number of pain medication doses per day.		in recovery room; post-operative days 1,3,5 & 7	No
Secondary	Total time until discharge from hospital.		Day of Surgery	No
Secondary	Mean visual analog scale pain number.		in recovery room; post-operative days 1,3,5 & 7	No
Secondary	Type of diet patient is able to tolerate.		post-opeartive days 1,3,5 & 7.	No