Pediatric Tonsillectomy Pain Reduction Study

Vanderbilt University Medical Center

Status and phase: Completed; Phase 3

Conditions: Postoperative Pain

Treatments: Drug: lidocaine (1%) + bupivacaine (0.5%); Drug: Lidocaine (1%) + Bupivacaine (0.5%) + Clonidine (25mcg); Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT00678379

080127

Details and patient eligibility

About

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).

Full 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).

Enrollment: 120 patients

Sex: All

Ages: 3 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 3 patient groups, including a placebo group

Normal Saline

Placebo Comparator group

Description:

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

Treatment:

Drug: Normal saline

Lidocaine (1%) + Bupivacaine 0.5%

Active Comparator group

Description:

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

Treatment:

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

Lidocaine + Bupivacaine + Clondine

Experimental group

Description:

Submucosal injection of 1.5 mL Lidocaine 1% + Bupivacaine 0.5% + Clondine 25mcg into the tonsillar fossa, pre-tonsillectomy

Treatment:

Drug: Lidocaine (1%) + Bupivacaine (0.5%) + Clonidine (25mcg)