Magnesium vs Placebo for Tonsillectomy

Ann & Robert H Lurie Children's Hospital of Chicago

Status and phase: Completed; Phase 3; Phase 2

Conditions: Pain

Treatments: Drug: Magnesium; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02218424

2014MagRCT

Details and patient eligibility

About

This study is a double-blind randomized controlled trial using intravenous magnesium versus placebo to determine if systemic magnesium can decrease postoperative pain in pediatric patients undergoing tonsillectomy.

Participants will be in one of two arms. Those in Arm 1 will receive magnesium (30 mg/kg bolus followed by a 10mg/kg/hr infusion) while those in Arm 2 will receive an equal volume of normal saline bolus followed by infusion (placebo).

The primary objective is to determine if systemic magnesium will decrease postoperative pain in patients undergoing tonsillectomy. The secondary objectives will determine if systemic magnesium administration is associated with a decrease in opioid-related side effects, decrease the incidence of emergence delirium, and improve postoperative functional recovery.

The study hypothesis is that the use of intravenous magnesium will decrease postoperative pain, decrease opioid-related side effects, decrease the incidence of emergence delirium, and improve functional recovery in patients undergoing tonsillectomy.

Enrollment: 60 patients

Sex: All

Ages: 4 to 10 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients aged 4-10 years old undergoing tonsillectomy by a single surgeon and under the care of that participating surgeon
• American Society of Anesthesiology (ASA) patient classification of I-III

Exclusion criteria

• Physical or developmental delay
• Psychiatric illness
• Current use of sedative or anticonvulsant medication
• Pre-existing renal disease
• Pre-existing cardiovascular disease
• Regular use of analgesic medication
• Having other procedures in addition to tonsillectomy (however, patients undergoing adenoidectomy with their tonsillectomy will be included in the study)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Magnesium

Experimental group

Description:

Intravenous magnesium. After IV placed intraoperatively, a bolus dose of magnesium 30 mg/kg is given over 15 minutes, followed by a continuous infusion of magnesium at 10 mg/kg/hr until the completion of the procedure.

Treatment:

Drug: Magnesium

Placebo infusion

Placebo Comparator group

Description:

Intravenous normal saline will be given as placebo. An equal amount of volume normal saline will be given intravenously as the control group.

Treatment:

Drug: Normal saline