Phase 4
Completed N=76
Combining Placing a Synera Patch With Propofol/Lidocaine Mixture to Decrease Pain With IV Propofol Injection
Pain on IV Injection of Propofol.
Source: ClinicalTrials.gov NCT02240628 ↗
Enrolled (actual)
76
Serious AEs
0.0%
Results posted
Jun 2016
Primary outcomePrimary: Number of Children in Each Group Who Don't Feel Pain or Have Mild Pain on Propofol Injection. — 29; 19 participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The main objective is to evaluate if combining placing the Synera patch and using Propofol /Lidocaine mixture will further decrease the pain associated with the IV injection of Propofol.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Children in Each Group Who Don't Feel Pain or Have Mild Pain on Propofol Injection. |
29; 19 | — |
| SECONDARY Pain Intensity |
20; 6; 9; 13; 1; 6 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy Children 6-17 yrs.
- Scheduled to receive general anesthesia for an elective procedure.
- ASA classification 1-2
Exclusion Criteria
- Children with Skin disease and/or Skin infections.
- Allergy to Propofol, Lidocaine or tetracaine.
Data sourced from ClinicalTrials.gov (NCT02240628). 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. Informational only — not medical advice.