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

The University of Texas System (UT)

Status and phase: Completed; Phase 4

Conditions: Pain on IV Injection of Propofol.

Treatments: Drug: Lidocaine; Device: Lidocaine/tetracaine transdermal patch; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02240628

HSC-MS-14-0323

Details and patient eligibility

About

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.

Full 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).

Enrollment: 76 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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76 participants in 2 patient groups, including a placebo group

Propofol-Lidocaine mixture

Active Comparator group

Description:

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.

Treatment:

Drug: Lidocaine

Device: Lidocaine/tetracaine transdermal patch

Propofol -Saline mixture

Placebo Comparator group

Description:

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.

Treatment:

Drug: Saline

Device: Lidocaine/tetracaine transdermal patch