Magnesium vs Placebo for Tonsillectomy
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 4 - 10 |
| Updated: | 1/5/2019 |
| Start Date: | October 2014 |
| End Date: | April 2015 |
Systemic Magnesium to Improve Postoperative Pain in Pediatric Patients Undergoing Tonsillectomy: A Randomized, Double Blinded, Placebo Controlled Trial
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.
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.
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)
We found this trial at
1
site
225 E Chicago Ave
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 227-4000
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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