Trial Outcomes & Findings for Combining Placing a Synera Patch With Propofol/Lidocaine Mixture to Decrease Pain With IV Propofol Injection (NCT NCT02240628)
NCT ID: NCT02240628
Last Updated: 2016-06-22
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
76 participants
Primary outcome timeframe
During propofol injection.
Results posted on
2016-06-22
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
38
|
|
Overall Study
COMPLETED
|
32
|
33
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Physician Decision
|
6
|
5
|
Baseline Characteristics
Combining Placing a Synera Patch With Propofol/Lidocaine Mixture to Decrease Pain With IV Propofol Injection
Baseline characteristics by cohort
| Measure |
Propofol-Lidocaine Mixture
n=32 Participants
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
n=33 Participants
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.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14.3750 years
STANDARD_DEVIATION 2.2683 • n=93 Participants
|
14.5455 years
STANDARD_DEVIATION 2.0930 • n=4 Participants
|
14.46025 years
STANDARD_DEVIATION 2.18065 • n=27 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=93 Participants
|
33 participants
n=4 Participants
|
65 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: During propofol injection.Outcome measures
| Measure |
Propofol-Lidocaine Mixture
n=32 Participants
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
n=33 Participants
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.
|
|---|---|---|
|
Number of Children in Each Group Who Don't Feel Pain or Have Mild Pain on Propofol Injection.
|
29 participants
|
19 participants
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Propofol-Lidocaine Mixture
n=32 Participants
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
n=33 Participants
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.
|
|---|---|---|
|
Pain Intensity
3
|
1 participants
|
6 participants
|
|
Pain Intensity
1
|
20 participants
|
6 participants
|
|
Pain Intensity
2
|
9 participants
|
13 participants
|
|
Pain Intensity
4
|
2 participants
|
8 participants
|
Adverse Events
Propofol-Lidocaine Mixture
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Propofol -Saline Mixture
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Propofol-Lidocaine Mixture
n=32 participants at risk
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
n=33 participants at risk
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.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.2%
2/32
|
3.0%
1/33
|
Additional Information
Dr. Samia Khalil
The University of Texas Health Science Center at Houston
Phone: 713-500-6242
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place