Combining Placing a Synera Patch With Propofol/Lidocaine Mixture to Decrease Pain With IV Propofol Injection
- Conditions
- Pain on IV Injection of Propofol.
- Interventions
- Registration Number
- NCT02240628
- 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.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
- Healthy Children 6-17 yrs.
- Scheduled to receive general anesthesia for an elective procedure.
- ASA classification 1-2
- Children with Skin disease and/or Skin infections.
- Allergy to Propofol, Lidocaine or tetracaine.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Propofol-Lidocaine mixture Lidocaine/tetracaine transdermal patch 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. Propofol-Lidocaine mixture Lidocaine 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. Propofol -Saline mixture Lidocaine/tetracaine transdermal patch 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. Propofol -Saline mixture Saline 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.
- Primary Outcome Measures
Name Time Method Number of Children in Each Group Who Don't Feel Pain or Have Mild Pain on Propofol Injection. During propofol injection.
- Secondary Outcome Measures
Name Time Method Pain Intensity 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).
Trial Locations
- Locations (1)
Memorial Hermann Hospital
🇺🇸Houston, Texas, United States