Memorial Hermann Hospital
Houston, Texas, 77030, United States
NCT Number: NCT02240628
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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Notify Me6 year–17 year
All sexes
Interventional
Phase 4
Houston, Texas, 77030, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All patients in arm 1 and arm 2 will receive the Synera Patch.
Other names: NDC 43469-864-01, Synera Patch
Patients in arm 2 will receive Saline with the Propofol.
Other names: 0.9% sodium chloride solution.
Patients in arm 1 will receive Lidocaine with the Propofol.
Time frame: During propofol injection.
Time frame: During Propofol injection.
A blinded independent observer will rate pain on Propofol injection according to a pain scale.
The University of Texas Health Science Center, Houston
Other
In Children, Placing a Synera Patch for Intravenous Access Combined With Administration of a Propofol-Lidocaine Mixture Decreases Pain Associated With Propofol Intravenous Injection.
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