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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propofol-Lidocaine mixture | Active Comparator | 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. |
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| Propofol -Saline mixture | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine/tetracaine transdermal patch | Device | All patients in arm 1 and arm 2 will receive the Synera Patch. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Children in Each Group Who Don't Feel Pain or Have Mild Pain on Propofol Injection. | During propofol injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity | A blinded independent observer will rate pain on Propofol injection according to a pain scale.
| During Propofol injection. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| samia khalil, M.D | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Hermann Hospital | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Saline | Drug | Patients in arm 2 will receive Saline with the Propofol. |
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| Lidocaine | Drug | Patients in arm 1 will receive Lidocaine with the Propofol. |
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| FG001 | 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. |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Children in Each Group Who Don't Feel Pain or Have Mild Pain on Propofol Injection. | Posted | Number | participants | During propofol injection. |
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| Secondary | Pain Intensity | A blinded independent observer will rate pain on Propofol injection according to a pain scale.
| Posted | Number | participants | During Propofol injection. |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 32 | 2 | 32 | ||
| EG001 | 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. | 0 | 33 | 1 | 33 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders | Erythema at site of the Synera patch was noted after removal of the patch which resolved by itself. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Samia Khalil | The University of Texas Health Science Center at Houston | 713-500-6242 | Samia.N.Khalil@uth.tmc.edu |
| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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| Male |
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| Participants |
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