Combining Placing a Synera Patch With Propofol/Lidocaine Mixture to Decrease Pain With IV Propofol Injection
NCT ID: NCT02240628
Last Updated: 2016-06-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
76 participants
INTERVENTIONAL
2014-08-31
2015-09-30
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Propofol-Lidocaine mixture
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.
Lidocaine/tetracaine transdermal patch
All patients in arm 1 and arm 2 will receive the Synera Patch.
Lidocaine
Patients in arm 1 will receive Lidocaine with the Propofol.
Propofol -Saline mixture
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.
Lidocaine/tetracaine transdermal patch
All patients in arm 1 and arm 2 will receive the Synera Patch.
Saline
Patients in arm 2 will receive Saline with the Propofol.
Interventions
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Lidocaine/tetracaine transdermal patch
All patients in arm 1 and arm 2 will receive the Synera Patch.
Saline
Patients in arm 2 will receive Saline with the Propofol.
Lidocaine
Patients in arm 1 will receive Lidocaine with the Propofol.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Scheduled to receive general anesthesia for an elective procedure.
* ASA classification 1-2
Exclusion Criteria
* Allergy to Propofol, Lidocaine or tetracaine.
6 Years
17 Years
ALL
Yes
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Samia Khalil
Professor Of Pediatric Anesthesia
Principal Investigators
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samia khalil, M.D
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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Memorial Hermann Hospital
Houston, Texas, United States
Countries
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Other Identifiers
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HSC-MS-14-0323
Identifier Type: -
Identifier Source: org_study_id
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