Pain on IV Injection of Propofol.
Conditions
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).
Interventions
DRUGSaline
Patients in arm 2 will receive Saline with the Propofol.
DRUGLidocaine
Patients in arm 1 will receive Lidocaine with the Propofol.
DEVICELidocaine/tetracaine transdermal patch
All patients in arm 1 and arm 2 will receive the Synera Patch.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Children in Each Group Who Don't Feel Pain or Have Mild Pain on Propofol Injection. | During propofol injection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 32 |
| 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. | 33 |
| Total | 65 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 6 | 5 |
Baseline characteristics
| Characteristic | Propofol-Lidocaine Mixture | Propofol -Saline Mixture | Total |
|---|---|---|---|
| Age, Continuous | 14.3750 years STANDARD_DEVIATION 2.2683 | 14.5455 years STANDARD_DEVIATION 2.093 | 14.46025 years STANDARD_DEVIATION 2.18065 |
| Region of Enrollment United States | 32 participants | 33 participants | 65 participants |
| Sex: Female, Male Female | 16 Participants | 14 Participants | 30 Participants |
| Sex: Female, Male Male | 16 Participants | 19 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 32 | 1 / 33 |
| serious Total, serious adverse events | 0 / 32 | 0 / 33 |
Outcome results
Primary
Number of Children in Each Group Who Don't Feel Pain or Have Mild Pain on Propofol Injection.
Time frame: During propofol injection.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Propofol-Lidocaine Mixture | Number of Children in Each Group Who Don't Feel Pain or Have Mild Pain on Propofol Injection. | 29 participants |
| Propofol -Saline Mixture | Number of Children in Each Group Who Don't Feel Pain or Have Mild Pain on Propofol Injection. | 19 participants |
Secondary
Pain Intensity
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).
Time frame: During Propofol injection.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Propofol-Lidocaine Mixture | Pain Intensity | 1 | 20 participants |
| Propofol-Lidocaine Mixture | Pain Intensity | 2 | 9 participants |
| Propofol-Lidocaine Mixture | Pain Intensity | 3 | 1 participants |
| Propofol-Lidocaine Mixture | Pain Intensity | 4 | 2 participants |
| Propofol -Saline Mixture | Pain Intensity | 4 | 8 participants |
| Propofol -Saline Mixture | Pain Intensity | 1 | 6 participants |
| Propofol -Saline Mixture | Pain Intensity | 3 | 6 participants |
| Propofol -Saline Mixture | Pain Intensity | 2 | 13 participants |