Magnesium vs Placebo for Tonsillectomy

NCT ID: NCT02218424

Last Updated: 2019-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-04-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Magnesium

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.

Group Type: EXPERIMENTAL

Magnesium

Intervention Type: DRUG

Placebo infusion

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

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

Interventions

Magnesium

Intervention Type: DRUG

Normal saline

Intervention Type: DRUG

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)

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Hubert Benzon

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hubert A Benzon, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Ann & Robert H Lurie Children's Hospital of Chicago

Locations

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

2014MagRCT

Identifier Type: -

Identifier Source: org_study_id