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NCT01342510 · ClinicalTrials.gov registry record · Phase 4
Combination of Magnesium and Lidocaine for the Pretreatment of Pain That is Caused by the Injection of Propofol
A Phase 4 study, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- Phase 4
- Development phase
- 200
- Enrollment target
NCT01342510: Completed Phase 4 study, sponsored by University of Wisconsin, Madison.
NCT01342510 is a Phase 4 study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 200 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01342510, a Phase 4 study, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 200 participants
- Enrollment target
Study Summary
Since the introduction of propofol into routine anesthesia practice, the phenomena of pain on injection has plagued anesthesia providers. Propofol, an unstable phenol, triggers the release of bradykinin on injection. This release causes a painful burning sensation in the patient at the site of injection. Anesthesia providers have attempted a large number of remedies to prevent this pain on injection. Previously explored ideas include injecting propofol into larger veins, warming of the hand with hot packs, and intravenous pretreatment with numerous other medications. Currently, pretreatment with lidocaine is commonly administered to prevent propofol injection pain. No studies to date have looked at the combination of lidocaine and magnesium in a single syringe for the pretreatment of pain on injection caused by propofol. In addition, the administration protocols that have been studied thus far do not mirror clinical practice at the University of Wisconsin. The investigators propose studying the use of magnesium and lidocaine in a single syringe for pretreatment of propofol related pain on injection.
Primary Outcome
Following injection of the study drug, 50 mg of propofol will be injected. Ten seconds after propofol, subjects will be asked a standard question about pain. Behavioral signs will be noted. Pain will be assessed using a four point scale: 0=no pain, 1=mild pain (pain reported only in response to questioning and without behavioral signs), 2=moderate pain (pain reported in response to questioning and a behavioral sign, or pain reported without questioning), 3=severe pain (strong vocal response or b
Interventions
- DRUG Lidocaine
- DRUG Magnesium Sulfate
- DRUG Control
- DRUG Lidocaine/Magnesium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2011-04 |
| Est. Completion | 2012-04 |
| Phase | Phase 4 |
What the finished NCT01342510 record still lists
NCT01342510 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 4 interventions - of which Lidocaine is the first listed.
NCT01342510 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01342510 about?
NCT01342510 is a clinical study titled "Combination of Magnesium and Lidocaine for the Pretreatment of Pain That is Caused by the Injection of Propofol". Since the introduction of propofol into routine anesthesia practice, the phenomena of pain on injection has plagued anesthesia providers. Propofol, an unstable phenol, triggers the release of bradykinin on injection. This release causes a painful burning sensation in the patient at the site of injec...
What is the current status of trial NCT01342510?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 200 participants. The study started on 2011-04. Estimated completion is 2012-04.
What interventions are being tested in trial NCT01342510?
The interventions under investigation include: Lidocaine (DRUG), Magnesium Sulfate (DRUG), Control (DRUG), Lidocaine/Magnesium (DRUG).
Who is sponsoring clinical trial NCT01342510?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01342510's enrollment target sits among peer trials
200 407th of 2000 higher than 1,556 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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