Pediatric Tonsillectomy Pain Reduction Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Lidocaine Infusion for Pain Relief in Children Scheduled for Tonsillectomy and Adenoidectomy

NCT03902314

Children, Only Tonsillar Hypertrophy Adenoid Hypertrophy

COMPLETED PHASE4

Comparison of Peritonsillar Infiltration of Tramadol Ketamine and Placebo on Pediatric Posttonsillectomy Pain

NCT03067103

Sleep Disorder; Breathing-Related Pain, Postoperative Child, Only

UNKNOWN PHASE4

Pain Management in Pediatric Adenotonsillectomy

NCT05928520

Pain Management

UNKNOWN PHASE3

Efficacy of Opioid-free Anesthesia in Reducing Postoperative Respiratory Depression in Children Undergoing Tonsillectomy

NCT02987985

Anesthesia General Anesthesia Analgesics, Opioid +14 more

COMPLETED PHASE3

Post-operative Pain Control After Pediatric Adenotonsillectomy

NCT02296840

Recurrent Tonsillitis Obstructive Sleep Apnea Sleep Disordered Breathing +1 more

TERMINATED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Normal Saline

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

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy.

A - normal saline

Lidocaine (1%) + Bupivacaine 0.5%

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

Group Type ACTIVE_COMPARATOR

lidocaine (1%) + bupivacaine (0.5%)

Intervention Type DRUG

Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy.

B - lidocaine (1%) + bupivacaine (0.5%)

Lidocaine + Bupivacaine + Clondine

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy.

C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

lidocaine (1%) + bupivacaine (0.5%)

Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy.

B - lidocaine (1%) + bupivacaine (0.5%)

Intervention Type DRUG

Normal saline

Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy.

A - normal saline

Intervention Type DRUG

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

Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy.

C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

3 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No