Pediatric Tonsillectomy Pain Reduction Study

Condition(s) targeted: Postoperative Pain

Intervention: lidocaine + bupivacaine (Drug); normal saline (Drug); lidocaine + bupivacaine + clonidine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Vanderbilt University

Official(s) and/or principal investigator(s):
Jonathan R Moss, MD, MPH, Principal Investigator, Affiliation: Vanderbilt University

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).

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

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

Primary outcome: Total number of post-operative doses of analgesics.

Secondary outcome:

Mean number of pain medication doses per day.

Total time until discharge from hospital.

Mean visual analog scale pain number.

Type of diet patient is able to tolerate.

Minimum age: 3 Years. Maximum age: 17 Years. Gender(s): Both.

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

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

Related 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.

Starting date: April 2008
Last updated: December 10, 2009