Pediatric Tonsillectomy Pain Reduction Study

NCT00678379 | Completed Phase 3 Results DMC

• 1 other identifier: 080127
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Postoperative Pain

Keywords

Tonsillectomy; Postoperative Pain; Clonidine; Anesthetics, Local

Outcome Measures

Primary Outcomes (1)

• Total Number of Post-operative Doses of Analgesics.

  The total number of intravenous fentanyl doses given PACU which will be compared between the three randomized groups (arms)

  Post-operative thru day 7

Secondary Outcomes (6)

• Median Number of Pain Medication Doses

  in recovery room

• Total Time Until Discharge From Hospital.

  Day of Surgery

• Mean Visual Analog Scale Pain Number.

  in recovery room; post-operative days 1,3,5 & 7

• Number and Percent of Participants Able to Tolerate Only Liquids

  post-operative days 1,3,5 & 7.

• Number and Percent of Participants Able to Tolerate Only a Soft Diet

  post-operative days 1,3,5 & 7.

Study Arms (3)

Normal Saline

PLACEBO COMPARATOR

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

Drug: Normal saline

Lidocaine (1%) + Bupivacaine 0.5%

ACTIVE COMPARATOR

Submucosal injection of 1.5 mL Lidocaine (1%) + Bupivacaine 0.5% into the tonsillar fossa, pre-tonsillectomy

Drug: lidocaine (1%) + bupivacaine (0.5%)

Lidocaine + Bupivacaine + Clondine

EXPERIMENTAL

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)

Interventions

lidocaine (1%) + bupivacaine (0.5%) DRUG

Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy. B - lidocaine (1%) + bupivacaine (0.5%)

Lidocaine (1%) + Bupivacaine 0.5%

Normal saline DRUG

Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy. A - normal saline

Normal Saline

Lidocaine (1%) + Bupivacaine (0.5%) + Clonidine (25mcg) DRUG

Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy. C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)

Lidocaine + Bupivacaine + Clondine

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Diagnosis of obstructive sleep apnea
• Patient with peritonsillar abscess
• Allergy to study medication
• Any major systemic illness, genetic disorder or diagnosed syndrome
• Bleeding disorder

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Monroe Carrel Jr. Children's Hospital

Nashville, Tennessee, 37299, United States

Location

Related Publications (7)

• 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.

  PMID: 17312203 BACKGROUND

• 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.

  PMID: 16159655 BACKGROUND

• 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.

  PMID: 17720118 BACKGROUND

• 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.

  PMID: 8436459 BACKGROUND

• 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.

  PMID: 1784501 BACKGROUND

• 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.

  PMID: 11587610 BACKGROUND

• 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.

  PMID: 21422302 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Lidocaine; Bupivacaine; Saline Solution; Clonidine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Jonathan Moss MD
• Organization: Charlotte Eye Ear Nose and Throat

jmoss@ceenta.com

704-295-3000

Study Officials

• Jonathan R Moss, MD, MPH

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: May 8, 2008
• First Posted: May 15, 2008
• Study Start: April 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: July 2, 2017
• Results First Posted: July 2, 2017

Record last verified: 2017-06

Locations

US (1)