Combining Placing a Synera Patch With Propofol/Lidocaine Mixture to Decrease Pain With IV Propofol Injection
Information source: The University of Texas Health Science Center, Houston
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain on IV Injection of Propofol.
Intervention: Lidocaine/tetracaine transdermal patch (Device); Saline (Drug); Lidocaine (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: The University of Texas Health Science Center, Houston Official(s) and/or principal investigator(s):
samia khalil, M.D, Principal Investigator, Affiliation: The University of Texas Health Science Center, Houston
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Number of children in each group who don't feel pain or have mild pain on Propofol injection.
Secondary outcome: Pain intensity
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).
Eligibility
Minimum age: 6 Years.
Maximum age: 17 Years.
Gender(s): Both.
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.
Locations and Contacts
Memorial Hermann Hospital, Houston, Texas 77030, United States; Recruiting
samia khalil, M.D, Phone: 713-500-6242
Samia Khalil, M.D, Principal Investigator
Additional Information
Starting date: August 2014
Last updated: September 11, 2014
|
