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Intravenous Lidocaine for Post-Tonsillectomy Pain in Pediatric Patients

Ann & Robert H Lurie Children's Hospital of Chicago logo

Ann & Robert H Lurie Children's Hospital of Chicago

Status and phase

Unknown
Phase 3
Phase 2

Conditions

Pain

Treatments

Drug: Lidocaine
Drug: Saline

Study type

Interventional

Funder types

Other

Identifiers

NCT02595463
2015-741

Details and patient eligibility

About

The purpose of this study is to determine whether giving lidocaine intravenously during and after a tonsillectomy surgery is effective in decreasing postoperative pain.

Full description

The purpose of this study is to determine whether giving lidocaine intravenously during and after a tonsillectomy surgery is effective in decreasing postoperative pain when compared to placebo.

Participants will be in one of two arms. Those in Arm 1 will receive a lidocaine bolus and infusion throughout the initial recovery period while those in Arm 2 will receive an equal volume of normal saline. Subjects will be monitored and assessed for pain during their time in the hospital and followed up on at home for a week after the surgery. Primary outcomes will be measure of pain. Secondary outcome measures will include pain medication use, emergence delirium, incidence of laryngospasm, and side effects.

Enrollment

90 estimated patients

Sex

All

Ages

4 to 10 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Scheduled for Tonsillectomy (with or without Adenoidectomy) with Dr. Kathleen Billings or Dr. Stephen Hoff at Lurie Children's Hospital
  • American Society of Anesthesiology (ASA) patient classification I-III (Healthy patient to a patient with mild systemic disease)

Exclusion criteria

  • Physical or developmental delays
  • Psychiatric illness
  • Current use of sedative or anticonvulsant medications
  • Pre-existing renal disease (ranging from stage 2 [mild] to stage 5 [end stage])
  • Pre-existing cardiovascular disease (including, not limited to congenital heart disease or arrythmia)
  • Pre-existing liver disease
  • Pre-existing cerebral or neuromuscular disease
  • Patient or family history of Malignant Hyperthermia
  • Recent history of upper respiratory infection within last 7 days
  • Regular use of analgesic medication
  • Diagnosis of severe obstructive sleep apnea requiring overnight stay for observation
  • Other procedure scheduled in addition to tonsillectomy
  • History of allergies to local anesthetics

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

90 participants in 2 patient groups, including a placebo group

Lidocaine
Experimental group
Description:
Following intraoperative IV placement, a 1.5 mg/kg bolus does of lidocaine hydrochloride is given and is followed by a continuous infusion of 2 mg/kg/hr until discharge from the Phase 1 recovery period.
Treatment:
Drug: Lidocaine
Placebo
Placebo Comparator group
Description:
Following intraoperative IV placement, a bolus of saline is given and is followed by a continuous infusion until discharge from the Phase 1 recovery period. The volume of the bolus and rate of infusion are equivalent to that which would have been given in the experimental arm.
Treatment:
Drug: Saline

Trial contacts and locations

1

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Central trial contact

John Hajduk

Data sourced from clinicaltrials.gov

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