Intravenous Lidocaine for Post-Tonsillectomy Pain in Pediatric Patients

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

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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