Trial Outcomes & Findings for Magnesium vs Placebo for Tonsillectomy (NCT NCT02218424)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

60 participants

Primary outcome timeframe

90 minutes

Results posted on

2019-01-03

Participant Flow

Participant milestones

Participant milestones
Measure	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. Magnesium	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. Normal saline
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Magnesium vs Placebo for Tonsillectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Magnesium n=30 Participants 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. Magnesium	Placebo Infusion n=30 Participants Intravenous normal saline will be given as placebo. An equal amount of volume normal saline will be given intravenously as the control group. Normal saline	Total n=60 Participants Total of all reporting groups
Age, Continuous	76.5 Months n=5 Participants	76.5 Months n=7 Participants	76.5 Months n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants
Body Mass Index	16.1 kg/m2 n=5 Participants	16.9 kg/m2 n=7 Participants	16.4 kg/m2 n=5 Participants
Obstructive Sleep Apnea (Yes/No) Yes	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Obstructive Sleep Apnea (Yes/No) No	23 Participants n=5 Participants	22 Participants n=7 Participants	45 Participants n=5 Participants
Surgical Duration	36.5 Minutes n=5 Participants	35 Minutes n=7 Participants	35 Minutes n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Magnesium n=30 Participants 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. Magnesium	Placebo Infusion n=30 Participants Intravenous normal saline will be given as placebo. An equal amount of volume normal saline will be given intravenously as the control group. Normal saline
Postoperative Pain	30 scores on a scale*minutes Interval 0.0 to 120.0	45 scores on a scale*minutes Interval 0.0 to 135.0

SECONDARY outcome

Timeframe: 90 minutes

Amount of rescue postoperative pain medication needed in the recovery room will be tabulated.

Outcome measures

Outcome measures
Measure	Magnesium n=30 Participants 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. Magnesium	Placebo Infusion n=30 Participants Intravenous normal saline will be given as placebo. An equal amount of volume normal saline will be given intravenously as the control group. Normal saline
Postoperative Pain Medication	2.0 mg IV morphine Interval 0.0 to 4.44	2.5 mg IV morphine Interval 0.0 to 4.99

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Magnesium n=30 Participants 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. Magnesium	Placebo Infusion n=30 Participants Intravenous normal saline will be given as placebo. An equal amount of volume normal saline will be given intravenously as the control group. Normal saline
Postoperative Pain at Home	5.5 PPPM Scale Score (Range: 0-15) Interval 4.0 to 7.0	5 PPPM Scale Score (Range: 0-15) Interval 2.0 to 7.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Magnesium n=30 Participants 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. Magnesium	Placebo Infusion n=30 Participants Intravenous normal saline will be given as placebo. An equal amount of volume normal saline will be given intravenously as the control group. Normal saline
Emergence Delirium	5 Units on a scale, PAED Interval 3.0 to 11.0	6.5 Units on a scale, PAED Interval 0.0 to 12.0

SECONDARY outcome

Timeframe: 90 minutes

The incidence of postoperative vomiting will be measured while in the recovery room.

Outcome measures

Outcome measures
Measure	Magnesium n=30 Participants 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. Magnesium	Placebo Infusion n=30 Participants Intravenous normal saline will be given as placebo. An equal amount of volume normal saline will be given intravenously as the control group. Normal saline
Number of Patients With Postoperative Vomiting	0 participants	0 participants

SECONDARY outcome

Timeframe: 90 minutes

The incidence of the presence of respiratory depression will be measured while the patient is in the recovery room.

Outcome measures

Outcome measures
Measure	Magnesium n=30 Participants 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. Magnesium	Placebo Infusion n=30 Participants Intravenous normal saline will be given as placebo. An equal amount of volume normal saline will be given intravenously as the control group. Normal saline
Respiratory Depression	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Approximately 90 minutes

The time to fulfilling discharge criteria, in minutes, from the PACU will be recorded

Outcome measures

Outcome measures
Measure	Magnesium n=30 Participants 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. Magnesium	Placebo Infusion n=30 Participants Intravenous normal saline will be given as placebo. An equal amount of volume normal saline will be given intravenously as the control group. Normal saline
Time to PACU Discharge	57 Minutes Standard Deviation 19	62 Minutes Standard Deviation 16

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Magnesium n=30 Participants 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. Magnesium	Placebo Infusion n=30 Participants Intravenous normal saline will be given as placebo. An equal amount of volume normal saline will be given intravenously as the control group. Normal saline
Parent Satisfaction	10 Units on a Numeric Rating Scale Interval 10.0 to 10.0	10 Units on a Numeric Rating Scale Interval 10.0 to 10.0

Adverse Events

Magnesium

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Infusion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Hubert Benzon, MD; Primary Investigator

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

Phone: 312-227-5122

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place