Phase 3 N=60 Randomized Quadruple-blind Treatment

Magnesium vs Placebo for Tonsillectomy

Pain

Bottom Line

View on ClinicalTrials.gov: NCT02218424 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2018

Primary outcome: Primary: Postoperative Pain — 30; 45 scores on a scale*minutes

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Magnesium (Drug); Normal saline (Drug)
Age: Pediatric · 4+ yrs
Sex: All
Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Primary completion: Apr 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Postoperative Pain	30; 45	—
SECONDARY Postoperative Pain Medication	2.0; 2.5	—
SECONDARY Postoperative Pain at Home	5.5; 5	—
SECONDARY Emergence Delirium	5; 6.5	—
SECONDARY Number of Patients With Postoperative Vomiting	0; 0	—
SECONDARY Respiratory Depression	0; 0	—
SECONDARY Time to PACU Discharge	57; 62	—
SECONDARY Parent Satisfaction	10; 10	—

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.

Eligibility Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02218424). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.