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Completed

NCT Number: NCT02240628

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

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Key information

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Memorial Hermann Hospital

Houston, Texas, 77030, United States

About this study

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.

  • No pain.
  • Mild Pain (associated with facial expression of pain).
  • Moderate Pain(Pulling the arm).
  • Severe Pain (screaming).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lidocaine/tetracaine transdermal patch

Device

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

Other names: NDC 43469-864-01, Synera Patch

Saline

Drug

Patients in arm 2 will receive Saline with the Propofol.

Other names: 0.9% sodium chloride solution.

Lidocaine

Drug

Patients in arm 1 will receive Lidocaine with the Propofol.

Primary outcomes

  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 outcomes

  1. Pain Intensity

    Time frame: During Propofol injection.

    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).

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study 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.

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 15, 2014
Registry last updated
Jun 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.