Combining Placing a Synera Patch With Propofol/Lidocaine Mixture to Decrease Pain With IV Propofol Injection

NCT02240628 | Completed Phase 4 Results

• 1 other identifier: HSC-MS-14-0323
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain on IV Injection of Propofol.

Outcome Measures

Primary Outcomes (1)

• Number of Children in Each Group Who Don't Feel Pain or Have Mild Pain on Propofol Injection.

  During propofol injection.

Secondary Outcomes (1)

• Pain Intensity

  During Propofol injection.

Study Arms (2)

Propofol-Lidocaine mixture

ACTIVE COMPARATOR

All patients from both groups will receive a Synera Patch. Patients in this group will receive Propofol mixed with Lidocaine. Pain will be evaluated during the Propofol injection by both a blinded observer and a blinded anesthesia member.

Device: Lidocaine/tetracaine transdermal patch; Drug: Lidocaine

Propofol -Saline mixture

PLACEBO COMPARATOR

All patients from both groups will receive a Synera Patch. Patienst in this group will receive Propofol mixed with Saline. Pain will be evaluated on Propofol injection by both a blinded observer and a blinded anesthesia member.

Device: Lidocaine/tetracaine transdermal patch; Drug: Saline

Interventions

Lidocaine/tetracaine transdermal patch DEVICE

All patients in arm 1 and arm 2 will receive the Synera Patch.

Also known as: NDC 43469-864-01, Synera Patch

Propofol -Saline mixture; Propofol-Lidocaine mixture

Saline DRUG

Patients in arm 2 will receive Saline with the Propofol.

Also known as: 0.9% sodium chloride solution.

Propofol -Saline mixture

Lidocaine DRUG

Patients in arm 1 will receive Lidocaine with the Propofol.

Propofol-Lidocaine mixture

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy Children 6-17 yrs.
• Scheduled to receive general anesthesia for an elective procedure.
• ASA classification 1-2

You may not qualify if:

• Children with Skin disease and/or Skin infections.
• Allergy to Propofol, Lidocaine or tetracaine.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Sodium Chloride; Lidocaine

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Samia Khalil
• Organization: The University of Texas Health Science Center at Houston

Samia.N.Khalil@uth.tmc.edu

713-500-6242

Study Officials

• samia khalil, M.D

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Of Pediatric Anesthesia

Study Record Dates

• First Submitted: September 11, 2014
• First Posted: September 15, 2014
• Study Start: August 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: June 22, 2016
• Results First Posted: June 22, 2016

Record last verified: 2016-05

Locations

US (1)