Clinical trial NCT00678379: Pediatric Tonsillectomy Pain Reduction Study
Official title: Pediatric Tonsillectomy Pain Reduction Study, a Randomized, Placebo Controlled, Double-Blind Clinical Trial Using Clonidine and Local Anesthetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Pain
Keywords: Tonsillectomy
Postoperative Pain
Clonidine
Anesthetics, Local
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2008-05-15
Enrollment: 120
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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 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

Primary outcomes:
measure: Total Number of Post-operative Doses of Analgesics.
timeFrame: Post-operative thru day 7
Secondary outcomes:
measure: Median Number of Pain Medication Doses
timeFrame: in recovery room
measure: Total Time Until Discharge From Hospital.
timeFrame: Day of Surgery
measure: Mean Visual Analog Scale Pain Number.
timeFrame: in recovery room; post-operative days 1,3,5 & 7
measure: Number and Percent of Participants Able to Tolerate Only Liquids
timeFrame: post-operative days 1,3,5 & 7.
measure: Number and Percent of Participants Able to Tolerate Only a Soft Diet
timeFrame: post-operative days 1,3,5 & 7.
measure: Number and Percent of Participants Able to Tolerate a Regular Diet
timeFrame: post-operative days 1,3,5 & 7.
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Monroe Carrel Jr. Children's Hospital
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Jonathan R Moss, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1213/01.ane.0000253548.97479.b8.
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. doi: 10.1016/j.ijporl.2005.03.020. Epub 2005 Apr 22.
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. doi: 10.1016/j.rapm.2007.02.010.
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. doi: 10.1016/0165-5876(93)90048-8.
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):305-308. doi: 10.1016/0304-3959(91)90220-R.
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. doi: 10.1001/archotol.127.10.1265.
citation: 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.