Magnesium vs Placebo for Tonsillectomy
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|ClinicalTrials.gov Identifier: NCT02218424|
Recruitment Status : Completed
First Posted : August 18, 2014
Results First Posted : December 14, 2018
Last Update Posted : January 3, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: Magnesium Drug: Normal saline||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Systemic Magnesium to Improve Postoperative Pain in Pediatric Patients Undergoing Tonsillectomy: A Randomized, Double Blinded, Placebo Controlled Trial|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2015|
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.
Placebo Comparator: 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.
Drug: Normal saline
- Postoperative Pain [ Time Frame: 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.
- Postoperative Pain Medication [ Time Frame: 90 minutes ]Amount of rescue postoperative pain medication needed in the recovery room will be tabulated.
- Postoperative Pain at Home [ Time Frame: 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.
- Emergence Delirium [ Time Frame: 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 [ Time Frame: 90 minutes ]The incidence of postoperative vomiting will be measured while in the recovery room.
- Respiratory Depression [ Time Frame: 90 minutes ]The incidence of the presence of respiratory depression will be measured while the patient is in the recovery room.
- Time to PACU Discharge [ Time Frame: Approximately 90 minutes ]The time to fulfilling discharge criteria, in minutes, from the PACU will be recorded
- Parent Satisfaction [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02218424
|United States, Illinois|
|Ann & Robert H. Lurie Children's Hospital of Chicago|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Hubert A Benzon, MD, MPH||Ann & Robert H Lurie Children's Hospital of Chicago|