NCT02218424

Magnesium vs Placebo for Tonsillectomy

Systemic Magnesium to Improve Postoperative Pain in Pediatric Patients Undergoing Tonsillectomy: A Randomized, Double Blinded, Placebo Controlled Trial

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago · Academic / Other
• Sex: All
• Age: 4 Years – 10 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Magnesium
DRUG	Normal saline

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2014-08-18
• Last updated: 2019-01-03
• Results posted: 2018-12-14

Locations

1 site across 1 country: United States