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Completed

NCT Number: NCT03902314

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

Lidocaine is widely available and is a very commonly used local anesthetic. When administered intravenously, lidocaine infusions have anti-inflammatory effects and have significantly decreased the reliance on opioid use for adequate pain management in adult abdominal and spine surgeries. A major advantage of lidocaine infusion is that it is not associated with a significant side effect profile.The role of lidocaine in pediatric acute perioperative pain remains limited.

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Key information

Conditions

Children, Only Adenoid Hypertrophy Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Tonsillar Hypertrophy

Age range

4 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hasbro Children's Hospital

Providence, Rhode Island, 02903, United States

About this study

The aim of the study is to determine if using lidocaine continuously during anesthesia care will decrease post-operative pain for children having their tonsils and adenoids removed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • scheduled tonsillectomy and adenoidectomy with or without myringotomy/PE tubes at Hasbro Children's Hospital

Exclusion criteria

  • history of allergies to local anesthetics
  • physical or developmental delays
  • psychiatric illness
  • current use of sedative or anticonvulsive medications
  • use of premedication (oral/nasal)
  • pre-existing cardiovascular, renal, or hepatic disease
  • pre-existing cerebral or neuromuscular disease
  • patient with personal or family history of malignant hyperthermia
  • recent history of upper respiratory infection within last 7 days
  • regular use of analgesic medications

Treatment and study plan

Lidocaine IV

Drug

Intravenous infusion

Saline Solution

Drug

Intravenous infusion

Primary outcomes

  1. Change in Pain Scores

    Time frame: 15 minute intervals in postanesthesia care unit; up to 120 minutes following surgery.

    FLACC scale includes 5 categories (Face, Legs, Activity, Cry, Consolability) of pain behaviors scored from 0-2 to provide a total pain score ranging from 0 to 10 with higher numbers indicating greater or worse pain.

Secondary outcomes

  1. Opioid consumption

    Time frame: Total perioperative period: time in the operating room until time of discharge to home from the postoperative anesthesia care unit (PACU)

    Morphine equivalents

  2. Emergence delirium scores

    Time frame: 5 minute intervals for the first 30 minutes in postanesthesia care unit, then every 15 minutes for an additional 90 minutes after surgery

    Pediatric Anesthesia Emergence Delirium (PAED) scale to differentiate emergence delirium from postoperative pain. The scale includes 5 categories (eye contact, purposefulness of actions, awareness of surroundings, restlessness, inconsolable) each scored from 0 to 4 to provide a total score ranging from 0 to 20 with higher numbers being worse indicating that the emergence behaviors correlate better with emergence delirium.

  3. Parental satisfaction with the anesthetic

    Time frame: Evaluated once on postoperative day 1 (or 24 hours after surgery)

    Measured on a scale from 0 to 10, where 0 means very unsatisfied and 10 means very satisfied; higher numbers are better

Sponsors and collaborators

Lead sponsor

Rhode Island Hospital

Other

Registry information

Official study title

Lidocaine Infusions for Children Undergoing Combined Tonsillectomy and Adenoidectomy: A Double-Blinded, Randomized, Placebo-Controlled Trial

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 4, 2019
Registry last updated
Jan 11, 2022

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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