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NCT Number: NCT00678379

Pediatric Tonsillectomy Pain Reduction Study

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).

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Key information

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Vanderbilt University Monroe Carrel Jr. Children's Hospital

Nashville, Tennessee, 37299, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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%)

normal saline

Drug

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

A - 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)

Primary outcomes

  1. Total Number of Post-operative Doses of Analgesics.

    Time frame: Post-operative thru day 7

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

Secondary outcomes

  1. Median Number of Pain Medication Doses

    Time frame: in recovery room

    The median number of intravenous fentanyl doses administered in the PACU due to pain

  2. Total Time Until Discharge From Hospital.

    Time frame: Day of Surgery

  3. Mean Visual Analog Scale Pain Number.

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

    Visual analog pain scale range is 0-10 with 0=no pain and 10 = worst pain ever

  4. Number and Percent of Participants Able to Tolerate Only Liquids

    Time frame: post-operative days 1,3,5 & 7.

    The number and percent of patients whose post-operative diet has advanced to liquids only on post-op days 1, 3, 5 & 7

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

    Time frame: post-operative days 1,3,5 & 7.

    The number and percent of patients whose post-operative diet has only advanced to a soft diet on post-operative days 1, 3, 5 & 7

  6. Number and Percent of Participants Able to Tolerate a Regular Diet

    Time frame: post-operative days 1,3,5 & 7.

    The number and percent of patients whose post-operative diet has to a regular diet on post-operative days 1, 3, 5 & 7

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 15, 2008
Registry last updated
Jul 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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