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NCT02218424 · ClinicalTrials.gov registry record · Phase 2
Magnesium vs Placebo for Tonsillectomy
A Phase 2 study of Pain, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT02218424: Completed Phase 2 study of Pain, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.
NCT02218424 is a Phase 2 study of Pain that has completed, run by Ann & Robert H Lurie Children's Hospital of Chicago. The registered enrollment target is 60 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02218424, a Phase 2 study of Pain, has completed, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
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 mo
Conditions Studied
Interventions
- DRUG Normal saline
- DRUG Magnesium
Study Locations (1)
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2014-10 |
| Est. Completion | 2015-04 |
| Phase | Phase 2 |
What the finished NCT02218424 record still lists
NCT02218424 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 304-participant average among 374 other Pain trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Pain appearing as the primary indexed condition, and to 2 interventions - of which Normal saline is the first listed.
NCT02218424 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT02218424 about?
NCT02218424 is a clinical study titled "Magnesium vs Placebo for Tonsillectomy". 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 m...
What is the current status of trial NCT02218424?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2014-10. Estimated completion is 2015-04.
What conditions does trial NCT02218424 study?
This clinical trial studies the following conditions: Pain.
What interventions are being tested in trial NCT02218424?
The interventions under investigation include: Normal saline (DRUG), Magnesium (DRUG).
Who is sponsoring clinical trial NCT02218424?
This trial is sponsored by Ann & Robert H Lurie Children's Hospital of Chicago, which has 159 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02218424 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02218424's enrollment target sits among peer trials
60 224th of 374 higher than 134 of 374 other Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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