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

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ClinicalTrials.gov Identifier: NCT02240628
Recruitment Status : Completed
First Posted : September 15, 2014
Results First Posted : June 22, 2016
Last Update Posted : June 22, 2016
Sponsor:
Information provided by (Responsible Party):
Samia Khalil, The University of Texas Health Science Center, Houston

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.

Condition or disease Intervention/treatment Phase
Pain on IV Injection of Propofol. Device: Lidocaine/tetracaine transdermal patch Drug: Saline Drug: Lidocaine Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: In Children, Placing a Synera Patch for Intravenous Access Combined With Administration of a Propofol-Lidocaine Mixture Decreases Pain Associated With Propofol Intravenous Injection.
Study Start Date : August 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


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 Name: 0.9% sodium chloride solution.




Primary Outcome Measures :
  1. Number of Children in Each Group Who Don't Feel Pain or Have Mild Pain on Propofol Injection. [ Time Frame: During propofol injection. ]

Secondary Outcome Measures :
  1. Pain Intensity [ Time Frame: During Propofol injection. ]

    A blinded independent observer will rate pain on Propofol injection according to a pain scale.

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



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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02240628


Locations
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United States, Texas
Memorial Hermann Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: samia khalil, M.D The University of Texas Health Science Center, Houston

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Responsible Party: Samia Khalil, Professor Of Pediatric Anesthesia, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02240628     History of Changes
Other Study ID Numbers: HSC-MS-14-0323
First Posted: September 15, 2014    Key Record Dates
Results First Posted: June 22, 2016
Last Update Posted: June 22, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Lidocaine
Tetracaine
Propofol
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General