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

Lifespan

Status and phase: Completed; Phase 4

Conditions: Children, Only; Adenoid Hypertrophy; Tonsillar Hypertrophy

Treatments: Drug: Lidocaine Iv; Drug: Saline Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT03902314

014118

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 70 patients

Sex: All

Ages: 4 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups, including a placebo group

Lidocaine

Active Comparator group

Description:

Lidocaine infusion at 2 mg/kg/hr will be started in the operating room and continue in the recovery period for 60 minutes.

Treatment:

Drug: Lidocaine Iv

Saline

Placebo Comparator group

Description:

Saline infusion at 2 mg/kg/hr will be started in the operating room and continue in the recovery period for 60 minutes.

Treatment:

Drug: Saline Solution