Phase 4
N=200
Combination of Magnesium and Lidocaine for the Pretreatment of Pain That is Caused by the Injection of Propofol
General Anesthesia · Intravenous Anesthesia
Bottom Line
View on ClinicalTrials.gov: NCT01342510 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Jun 2012
Primary outcome: Primary: Percentage of Participants Reporting Pain With Injection of Propofol — 29; 57; 41; 46 percentage of patients reporting pain
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Magnesium Sulfate (Drug); Lidocaine (Drug); Control (Drug); Lidocaine/Magnesium (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Reporting Pain With Injection of Propofol |
29; 57; 41; 46 | — |
| PRIMARY Number of Patients With Pain Associated With Injection of Propofol. |
11; 25; 15; 18 | — |
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.
Eligibility Criteria
Inclusion Criteria
- All adults American Society of Anesthesiologists (ASA) physical status 1 and 2 patients selected for general anesthesia.
Exclusion Criteria
- age < 18 years
- allergy to local anesthetics
- end stage renal disease
- pregnancy
- prisoners
- patients requiring a rapid sequence induction
- refusal to participate and patients already participating in another study
Data sourced from ClinicalTrials.gov (NCT01342510). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.