Phase 4
N=156
Preventing Propofol-associated Injection Pain
Pain
Bottom Line
View on ClinicalTrials.gov: NCT00864682 ↗Enrolled (actual)
156
Serious AEs
0.0%
Results posted
Aug 2009
Primary outcome: Primary: Verbal Pain Score — 3; 0; 0 Units on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Saline (Drug); Lidocaine / propofol admixture (Drug); lidocaine pretreatment (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Benaroya Research Institute
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Verbal Pain Score |
3; 0; 0 | <0.0001 sig |
| SECONDARY Complete Alleviation of Injection Pain |
14; 28; 40 | <0.008 sig |
| SECONDARY Satisfaction With Anesthetic Technique |
42; 48; 51; 8; 2; 0 | — |
Summary
Injection of propofol is associated with discomfort in subsets of patients. Local anesthetics have been shown to attenuate this response in some patients. This randomized, double-blind, placebo-controlled trial tests the hypothesis that lidocaine mixed with propofol will be superior to lidocaine administered directly into the vein, under tourniquet control, prior to injection of propofol. Both groups are expected to be superior to placebo.
Eligibility Criteria
Inclusion criteria
- weight >40kg, <100kg
- ambulatory surgery
Exclusion criteria
- allergy to propofol or lidocaine
- taking opioids, benzodiazepines, or nonsteroidal antiinflammatory drugs (NSAIDs)
Data sourced from ClinicalTrials.gov (NCT00864682). 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.