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

In Children, Placing a Synera Patch for Intravenous Access Combined With Administration of a Propofol-Lidocaine Mixture Decreases Pain Associated With Propofol Intravenous Injection.

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.

Study Overview

• Status: Completed
• Conditions: Pain on IV Injection of Propofol.
• Intervention / Treatment: Device: Lidocaine/tetracaine transdermal patch; Drug: Lidocaine; Drug: Saline

Detailed Description

Commonly, anesthesiologists inject Propofol, a sleeping medication, intravenously to induce general anesthesia.Propofol injection is commonly associated with burning pain. In a previous onsite study we concluded that placing a Synera patch at least 30 minutes before placing the IV decreased the pain associated with the Propofol injection. Also,a study documented that adding Lidocaine to the Propofol decreases the pain associated with propofol injection. In our study here we are trying to evaluate if combining the use of both the Synera patch and the Propofol-Lidocaine mixture will further decrease the pain associated with the IV Propofol injection.

All children will receive a Synera Patch, it will be placed on the dorsum of both hands for at least 30 minutes.All Children will be Sedated with P.O Versed.

22 g IV will be started either in the holding area or in the OR. Children will be randomized into groups using a computer generated randomization list:- Group 1 will receive Propofol -Lidocaine mixture. Group 2 will receive Propofol-Saline mixture. An independent blinded observer and an anesthesia member will independently evaluate pain on Propofol injection according to pain scale.

1. No pain.
2. Mild Pain (associated with facial expression of pain).
3. Moderate Pain(Pulling the arm).
4. Severe Pain (screaming).

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Memorial Hermann Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Propofol-Lidocaine mixture; 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; All patients in arm 1 and arm 2 will receive the Synera Patch.; Other Names: NDC 43469-864-01; Synera Patch; Drug: Lidocaine; Patients in arm 1 will receive Lidocaine with the Propofol.
Placebo Comparator: Propofol -Saline mixture; 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; All patients in arm 1 and arm 2 will receive the Synera Patch.; Other Names: NDC 43469-864-01; Synera Patch; Drug: Saline; Patients in arm 2 will receive Saline with the Propofol.; Other Names: 0.9% sodium chloride solution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Children in Each Group Who Don't Feel Pain or Have Mild Pain on Propofol Injection.	During propofol injection.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity	A blinded independent observer will rate pain on Propofol injection according to a pain scale.; No pain.; Mild pain(associated with facial expression of pain).; Moderate Pain(Pulling/withdrawal of arm).; Severe Pain(Screaming).	During Propofol injection.

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: samia khalil, M.D, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: September 11, 2014
• First Submitted That Met QC Criteria: September 11, 2014
• First Posted (Estimate): September 15, 2014

Study Record Updates

• Last Update Posted (Estimate): June 22, 2016
• Last Update Submitted That Met QC Criteria: May 13, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Tetracaine
• Other Study ID Numbers: HSC-MS-14-0323