Magnesium vs Placebo for Tonsillectomy

Phase 2

Completed

Conditions: Pain

Interventions: Drug: Normal saline
Drug: Magnesium

Registration Number: NCT02218424

Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 60

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo infusion	Normal saline	Intravenous normal saline will be given as placebo. An equal amount of volume normal saline will be given intravenously as the control group.
Magnesium	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.

Primary Outcome Measures

Name	Time	Method
Postoperative Pain	90 minutes	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.

Secondary Outcome Measures

Name	Time	Method
Time to PACU Discharge	Approximately 90 minutes	The time to fulfilling discharge criteria, in minutes, from the PACU will be recorded
Emergence Delirium	5 minutes after awakening in the recovery room	The incidence of emergence delirium determined using the pediatric anesthesia emergence delirium (PAED) scale while the patient is in the PACU. The PAED scale ranges from scores of 0 to 20, with lower scores indicating less agitation, more awareness, less aggressiveness, and a more favorable outcome in the post-anesthesia recovery period.
Number of Patients With Postoperative Vomiting	90 minutes	The incidence of postoperative vomiting will be measured while in the recovery room.
Respiratory Depression	90 minutes	The incidence of the presence of respiratory depression will be measured while the patient is in the recovery room.
Parent Satisfaction	7 days	Parent satisfaction will be assessed on postoperative days 1, 3, and 7. This will be determined by asking the parents one question about their satisfaction with the overal anesthetic care on a numeric rating scale of 1 to 10, with higher scores indicating greater satisfaction and better outcome.
Postoperative Pain Medication	90 minutes	Amount of rescue postoperative pain medication needed in the recovery room will be tabulated.
Postoperative Pain at Home	7 days	Postoperative pain at home will be measured using the Parent's Post-Operative Pain Measure (PPPM) questionnaire on postoperative days 1, 3, and 7. The PPPM gives a score to child behavior which suggests they are in pain after surgery with scores ranging from 0 to 15 with lower values suggesting better pain outcome.