Magnesium vs Placebo for Tonsillectomy

NCT02218424 | Completed Phase 2 Results DMC

• 1 other identifier: 2014MagRCT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain

  Postoperative pain will be measured at 15 minute time intervals in the post-anesthesia care unit (PACU). Pain scores will be evaluated using a standardized validated scale (the Faces Pain Scale Revised (FPS-R)). The Faces Pain Scale is a validated, patient reported, 0 (no pain) to 10 (worst pain imaginable) numeric rating scale. Pain scores will be multiplied by the time spent at each pain score for a calculated "Area Under the Curve" value, ranging from 0 to 900, with lower values indicating more favorable and lower pain scores.

  90 minutes

Secondary Outcomes (7)

• Postoperative Pain Medication

  90 minutes

• Postoperative Pain at Home

  7 days

• Emergence Delirium

  5 minutes after awakening in the recovery room

• Number of Patients With Postoperative Vomiting

  90 minutes

• Respiratory Depression

  90 minutes

Study Arms (2)

Magnesium

EXPERIMENTAL

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.

Drug: Magnesium

Placebo infusion

PLACEBO COMPARATOR

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

Drug: Normal saline

Interventions

Magnesium DRUG

Magnesium

Normal saline DRUG

Placebo infusion

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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)

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead

Study Sites (1)

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

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Magnesium; Saline Solution

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals, Light; Metals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Hubert Benzon, MD; Primary Investigator
• Organization: Ann & Robert H. Lurie Children's Hospital of Chicago

hbenzon@luriechildrens.org

312-227-5122

Study Officials

• Hubert A Benzon, MD, MPH

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 12, 2014
• First Posted: August 18, 2014
• Study Start: October 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: January 3, 2019
• Results First Posted: December 14, 2018

Record last verified: 2018-12

Locations

US (1)