Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2025-12-26 @ 2:12 PM
Study NCT ID:
NCT07126795
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-22
First Post:
2025-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnesium Sulfate in Pediatric Burn Dressing Changes
Sponsor:
Hennepin Healthcare Research Institute
Organization:
Study Overview
Official Title:
Magnesium Sulfate for Adjuvant Analgesia in Pediatric Burn Dressing Changes: a Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Prospective feasibility trial utilizing adjuvant magnesium sulfate for analgesia/sedation during pediatric sedated burn dressing changes, which is ultimately hypothesized to decrease ketamine and/or sedative requirements.
Detailed Description:
Pediatric patients (n=10) suffering severe burn, admitted to the burn unit at Hennepin County Medical Center (Minneapolis, MN) meeting specific inclusion/exclusion criteria will be randomized daily to either intravenous magnesium sulfate (50 mg/kg, max 2 g) or placebo (normal saline) for up to 5 sedated burn dressing changes. Primary aims will be to evaluate safety/feasibility to guide a future larger randomized controlled trial.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: