Magnesium vs Placebo for Tonsillectomy

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Pain

In brief

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.

Key facts

Study ID

NCT02218424

Run by

Ann & Robert H Lurie Children's Hospital of Chicago

People needed

60

Starts

2014-10-01

Expected to finish

2015-04-01

Last updated by the study team

2019-01-03

Who can join

Age: 4 and older, up to 10. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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