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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

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing if a numbing patch called Synera can reduce the pain children feel when getting a propofol injection for anesthesia. The patch contains medicines that numb the skin, making the needle hurt less.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within one hour, plus or minus one half hour

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of children in each group who do not feel pain or have mild pain on propofol injection.

Secondary study objectives

Pain intensity

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

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