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Synera Patch for Propofol Injection Pain (Synera patch Trial)

Phase 4
Waitlist Available
Led By Samia N Khalil, M.D.
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within one hour, plus or minus one half hour
Awards & highlights

Synera patch Trial Summary

The purpose of this study is to evaluate if the Synera Patch (lidocaine/tetracaine patch), used to numb the skin before IV placement, is effective in reducing pain associated with propofol IV administration when inducing general anesthesia, compared to Gebauer's Ethyl Chloride topical anesthetic skin refrigerant.

Synera patch Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within one hour, plus or minus one half hour
This trial's timeline: 3 weeks for screening, Varies for treatment, and within one hour, plus or minus one half hour for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of children in each group who do not feel pain or have mild pain on propofol injection.
Secondary outcome measures
Pain intensity

Synera patch Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Synera PatchExperimental Treatment1 Intervention
The other half of the patients will randomly be assigned to receive Synera Patches, to be applied to the dorsum of both hands, at least 30 minutes before placing a 22 gauge intravenous catheter. Pain in this group will be evaluated at the time of IV placement by an independent observer (unblinded) and the patient on a 0-10 scale. Pain will again be evaluated when propofol is injected at anesthesia induction by a blinded observer and the staff anesthesiologist (also blinded) on a scale of 1-4. Blinding will occur following IV placement by draping and securing the hand and IV site with Coban self-adherent elastic wrap to cover any skin changes due to the patch or ethyl chloride.
Group II: ethyl chloride vapocoolant sprayActive Control1 Intervention
Half of the patients will randomly be assigned to receive Gebauer's ethyl choride topical anesthetic vapo-coolant spray immediately prior to placing a 22 gauge intravenous catheter. Pain in this group will be evaluated at the time of IV placement by an independent observer (unblinded) and the patient on a 0-10 scale. Pain will again be evaluated when propofol is injected at anesthesia induction by a blinded observer and the staff anesthesiologist (also blinded) on a scale of 1-4. Blinding will occur following IV placement by draping and securing the hand and IV site with Coban self-adherent elastic wrap to cover any skin changes due to the ethyl chloride or the patch.

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
904 Previous Clinical Trials
320,917 Total Patients Enrolled
ZARS Pharma Inc.Industry Sponsor
25 Previous Clinical Trials
2,579 Total Patients Enrolled
Samia N Khalil, M.D.Principal InvestigatorUniversity of Texas Health Sciences Center at Houston
1 Previous Clinical Trials
31 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
In Children, Does Using a Synera Patch Decrease Pain When Injecting Propofol at Anesthesia Induction?
Samia Khalil 2012. "In Children, Does Using a Synera Patch Decrease Pain When Injecting Propofol at Anesthesia Induction?". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01576770.
All > Anesthesia
~6 spots leftby Apr 2025
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