Magnesium vs Placebo for Tonsillectomy

Study Overview
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Brief Summary
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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.

Official Title
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Systemic Magnesium to Improve Postoperative Pain in Pediatric Patients Undergoing Tonsillectomy: A Randomized, Double Blinded, Placebo Controlled Trial

Conditions
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Pain

Intervention / Treatment
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* Drug: Magnesium
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magnesium<br>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<br> <br> |
| Placebo Comparator: Placebo infusion<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Pain Medication | Amount of rescue postoperative pain medication needed in the recovery room will be tabulated. | 90 minutes | 
| Postoperative Pain at Home | 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. | 7 days | 
| Emergence Delirium | 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. | 5 minutes after awakening in the recovery room | 
| Number of Patients With Postoperative Vomiting | The incidence of postoperative vomiting will be measured while in the recovery room. | 90 minutes | 
| Respiratory Depression | The incidence of the presence of respiratory depression will be measured while the patient is in the recovery room. | 90 minutes | 
| Time to PACU Discharge | The time to fulfilling discharge criteria, in minutes, from the PACU will be recorded | Approximately 90 minutes | 
| Parent Satisfaction | 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. | 7 days |