Pain on IV Injection of Propofol.Phase 4NCT02240628
Combining Placing a Synera Patch With Propofol/Lidocaine Mixture to Decrease Pain With IV Propofol Injection
A Phase 4 study testing Lidocaine/tetracaine transdermal patch, Saline and Lidocaine in people with Pain on IV Injection of Propofol., run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain on IV Injection of Propofol.
- What is being tested?
- Lidocaine/tetracaine transdermal patch, Saline and Lidocaine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Sep 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy Children 6-17 yrs.
- Scheduled to receive general anesthesia for an elective procedure.
- ASA classification 1-2
Who cannot join
- Children with Skin disease and/or Skin infections.
- Allergy to Propofol, Lidocaine or tetracaine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In Children, Placing a Synera Patch for Intravenous Access Combined With Administration of a Propofol-Lidocaine Mixture Decreases Pain Associated With Propofol Intravenous Injection.
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.
Read the 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.
- No pain.
- Mild Pain (associated with facial expression of pain).
- Moderate Pain(Pulling the arm).
- Severe Pain (screaming).
- Conditions
- Pain on IV Injection of Propofol.
- Being tested
- Lidocaine/tetracaine transdermal patch, Saline, Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine/tetracaine transdermal patchDevice
Also called NDC 43469-864-01, Synera Patch
All patients in arm 1 and arm 2 will receive the Synera Patch.
SalineDrug
Also called 0.9% sodium chloride solution.
Patients in arm 2 will receive Saline with the Propofol.
LidocaineDrug
Patients in arm 1 will receive Lidocaine with the Propofol.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Lidocaine/tetracaine transdermal patch; Drug: Lidocaine |
| 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. Receives: Device: Lidocaine/tetracaine transdermal patch; Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Children in Each Group Who Don't Feel Pain or Have Mild Pain on Propofol Injection.
Measured: During propofol injection.
Secondary outcomes (1)
Pain Intensity
A blinded independent observer will rate pain on Propofol injection according to a pain scale.
- No pain.
- Mild pain(associated with facial expression of pain).
- Moderate Pain(Pulling/withdrawal of arm).
- Severe Pain(Screaming).
Measured: During Propofol injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain on IV Injection of Propofol.Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samia Khalil, The University of Texas Health Science Center, Houston
- Investigators
- samia khalil, M.D, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02240628
- Sponsor's protocol ID
- HSC-MS-14-0323
- Status last verified
- May 2016
- First submitted
- 11 Sep 2014
- Last updated
- 22 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Children, Placing a Synera Patch for Intravenous Access Combined With Administration of a Propofol-Lidocaine Mixture Decreases Pain Associated With Propofol Intravenous Injection.
- ClinicalTrials.gov ID
- NCT02240628
- Acronym / sponsor ID
- HSC-MS-14-0323
- Conditions
- Pain on IV Injection of Propofol.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 15 Sep 2014 (estimated)
- Results
- Posted 22 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- No pain.
- Mild Pain (associated with facial expression of pain).
- Moderate Pain(Pulling the arm).
- Severe Pain (screaming).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol-Lidocaine mixture | Active comparator | Device: Lidocaine/tetracaine transdermal patch, Drug: LidocaineAll 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. |
| Propofol -Saline mixture | Placebo comparator | Device: Lidocaine/tetracaine transdermal patch, Drug: SalineAll 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. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy Children 6-17 yrs.
- Scheduled to receive general anesthesia for an elective procedure.
- ASA classification 1-2
Key exclusion criteria (2 listed)
- Children with Skin disease and/or Skin infections.
- Allergy to Propofol, Lidocaine or tetracaine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine/tetracaine transdermal patchAlso: NDC 43469-864-01, Synera PatchAll patients in arm 1 and arm 2 will receive the Synera Patch. | Device | Propofol -Saline mixture, Propofol-Lidocaine mixture |
| SalineAlso: 0.9% sodium chloride solution.Patients in arm 2 will receive Saline with the Propofol. | Drug | Propofol -Saline mixture |
| LidocainePatients in arm 1 will receive Lidocaine with the Propofol. | Drug | Propofol-Lidocaine mixture |
Primary outcome
Number of Children in Each Group Who Don't Feel Pain or Have Mild Pain on Propofol Injection.
Time frame: During propofol injection.
1 secondary outcome
Pain Intensity
Time frame: During Propofol injection.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Pain on IV Injection of Propofol.
Not yet recruiting
Comparative Efficacy of IV Parecoxib vs Lidocaine in Reducing Propofol Injection Pain
Preventing Propofol Pain on Injection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
samia khalil, M.D principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine/tetracaine transdermal patch, Saline and Lidocaine in people with Pain on IV Injection of Propofol., run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Children in Each Group Who Don't Feel Pain or Have Mild Pain on Propofol Injection. (time frame: During propofol injection.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2016.