Pain on Propofol IV InjectionPhase 4Synera patchNCT01576770
In Children, Does Using a Synera Patch Decrease Pain When Injecting Propofol at Anesthesia Induction?
A Phase 4 study testing lidocaine/tetracaine transdermal patch (NDC 43469-864-01) and Gebauer's Ethyl Chloride in people with Pain on Propofol IV Injection, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to evaluate if the Synera Patch (lidocaine/tetracaine patch), used to numb the skin before IV placement, is effective in reducing pain associated with propofol IV administration when inducing general anesthesia, compared to Gebauer's Ethyl Chloride topical anesthetic skin refrigerant. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Pain on Propofol IV Injection
- What is being tested?
- lidocaine/tetracaine transdermal patch (NDC 43469-864-01) and Gebauer's Ethyl Chloride
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Jan 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Child
Who may be able to join
- Healthy, outpatient children, 6-17 years old
- American Society of Anesthesiologist Physical Classification rating of 1 or 2
- Elective procedure requiring general anesthesia at Memorial Herman Hospital, The Medical Center, Houston, Texas
Who cannot join
- Skin disease or infection (on dorsum of hands)
- Allergy to lidocaine or tetracaine
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Memorial Herman Hospital
Houston, Texas, 77030
About this study
Official title: In Children, Does the Use of Synera Patch for Local Analgesia Before Vascular Access Reduce Pain Associated With Propofol Injection for Anesthesia Induction?
The purpose of this study is to evaluate if the Synera Patch (lidocaine/tetracaine patch), used to numb the skin before IV placement, is effective in reducing pain associated with propofol IV administration when inducing general anesthesia, compared to Gebauer's Ethyl Chloride topical anesthetic skin refrigerant.
Read the detailed description
Commonly, anesthesiologists inject Propofol, a sleeping medication, intravenously to induce general anesthesia. Propofol injection is associated with pain that can be severe.
The investigators also place a lidocaine/tetracaine skin patch (Synera) to decrease pain associated with IV placement. Because the local anesthetics of the Synera patch diffuse deep underneath the skin, in this study the investigators would like to evaluate whether the application of Synera Patch can decrease the pain associated with propofol injection.
Children will be randomized to receive either the patch or the Ethyl Chloride before the IV placement. A total of 33 patients will be enrolled in each group.
- Conditions
- Pain on Propofol IV Injection
- Being tested
- lidocaine/tetracaine transdermal patch (NDC 43469-864-01), Gebauer's Ethyl Chloride
- Keywords
- propofol, Pain, Synera Patch, Gebauer's Ethyl Chloride topical anesthetic
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaine/tetracaine transdermal patch (NDC 43469-864-01)Device
Also called NDC 43469-864-01
70 mg lidocaine / 70 mg tetracaine
Gebauer's Ethyl ChlorideDrug
Also called CHLOROETHANE, HYDROCHLORIC ETHER, NDC 45951-0123
Spray is to be applied topically to skin (dorsum of the hand for study purposes)until it turns white or for up to 10 seconds.
| Study group | Role | What they receive |
|---|---|---|
| ethyl chloride vapocoolant spray | Active comparator | Half of the patients will randomly be assigned to receive Gebauer's ethyl choride topical anesthetic vapo-coolant spray immediately prior to placing a 22 gauge intravenous catheter.
Pain in this group will be evaluated at the time of IV placement by an independent observer (unblinded) and the patient on a 0-10 scale. Pain will again be evaluated when propofol is injected at anesthesia induction by a blinded observer and the staff anesthesiologist (also blinded) on a scale of 1-4.
Blinding will occur following IV placement by draping and securing the hand and IV site with Coban self-adherent elastic wrap to cover any skin changes due to the ethyl chloride or the patch. Receives: Drug: Gebauer's Ethyl Chloride |
| Synera Patch | Experimental | The other half of the patients will randomly be assigned to receive Synera Patches, to be applied to the dorsum of both hands, at least 30 minutes before placing a 22 gauge intravenous catheter.
Pain in this group will be evaluated at the time of IV placement by an independent observer (unblinded) and the patient on a 0-10 scale. Pain will again be evaluated when propofol is injected at anesthesia induction by a blinded observer and the staff anesthesiologist (also blinded) on a scale of 1-4.
Blinding will occur following IV placement by draping and securing the hand and IV site with Coban self-adherent elastic wrap to cover any skin changes due to the patch or ethyl chloride. Receives: Device: lidocaine/tetracaine transdermal patch (NDC 43469-864-01) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of children in each group who do not feel pain or have mild pain on propofol injection.
The primary outcome variable is the success/failure of therapy. The therapy is considered a success if a child feels no pain OR has mild pain.
Measured: Within one hour, plus or minus one half hour
Secondary outcomes (1)
Pain intensity
A blinded independent observer and a blinded anesthesiologist 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 the arm)
- - severe pain (screaming)
Measured: Within one hour, plus or minus one half hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionOct 2012 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain on Propofol IV InjectionStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- ZARS Pharma Inc.
- Responsible party
- Principal investigator, Samia Khalil, The University of Texas Health Science Center, Houston
- Investigators
- Samia N Khalil, M.D., Principal investigator, University of Texas Health Sciences Center at Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01576770
- Sponsor's protocol ID
- HSC-MS-12-0042
- Acronym
- Synera patch
- Status last verified
- Apr 2012
- First submitted
- 10 Apr 2012
- Last updated
- 12 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Children, Does the Use of Synera Patch for Local Analgesia Before Vascular Access Reduce Pain Associated With Propofol Injection for Anesthesia Induction?
- ClinicalTrials.gov ID
- NCT01576770
- Acronym / sponsor ID
- Synera patch / HSC-MS-12-0042
- Conditions
- Pain on Propofol IV Injection
- Keywords
- propofol, Pain, Synera Patch, Gebauer's Ethyl Chloride topical anesthetic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- ZARS Pharma Inc.
- Study start
- Apr 2012
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 12 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate if the Synera Patch (lidocaine/tetracaine patch), used to numb the skin before IV placement, is effective in reducing pain associated with propofol IV administration when inducing general anesthesia, compared to Gebauer's Ethyl Chloride topical anesthetic skin refrigerant.
Detailed description
Commonly, anesthesiologists inject Propofol, a sleeping medication, intravenously to induce general anesthesia. Propofol injection is associated with pain that can be severe.
The investigators also place a lidocaine/tetracaine skin patch (Synera) to decrease pain associated with IV placement. Because the local anesthetics of the Synera patch diffuse deep underneath the skin, in this study the investigators would like to evaluate whether the application of Synera Patch can decrease the pain associated with propofol injection.
Children will be randomized to receive either the patch or the Ethyl Chloride before the IV placement. A total of 33 patients will be enrolled in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ethyl chloride vapocoolant spray | Active comparator | Drug: Gebauer's Ethyl ChlorideHalf of the patients will randomly be assigned to receive Gebauer's ethyl choride topical anesthetic vapo-coolant spray immediately prior to placing a 22 gauge intravenous catheter. Pain in this group will be evaluated at the time of IV placement by an independent observer (unblinded) and the patient on a 0-10 scale. Pain will again be evaluated when propofol is injected at anesthesia induction by a blinded observer and the staff anesthesiologist (also blinded) on a scale of 1-4. Blinding will occur following IV placement by draping and securing the hand and IV site with Coban self-adherent elastic wrap to cover any skin changes due to the ethyl chloride or the patch. |
| Synera Patch | Experimental | Device: lidocaine/tetracaine transdermal patch (NDC 43469-864-01)The other half of the patients will randomly be assigned to receive Synera Patches, to be applied to the dorsum of both hands, at least 30 minutes before placing a 22 gauge intravenous catheter. Pain in this group will be evaluated at the time of IV placement by an independent observer (unblinded) and the patient on a 0-10 scale. Pain will again be evaluated when propofol is injected at anesthesia induction by a blinded observer and the staff anesthesiologist (also blinded) on a scale of 1-4. Blinding will occur following IV placement by draping and securing the hand and IV site with Coban self-adherent elastic wrap to cover any skin changes due to the patch or ethyl chloride. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy, outpatient children, 6-17 years old
- American Society of Anesthesiologist Physical Classification rating of 1 or 2
- Elective procedure requiring general anesthesia at Memorial Herman Hospital, The Medical Center, Houston, Texas
Key exclusion criteria (2 listed)
- Skin disease or infection (on dorsum of hands)
- Allergy to 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 patch (NDC 43469-864-01)Also: NDC 43469-864-0170 mg lidocaine / 70 mg tetracaine | Device | Synera Patch |
| Gebauer's Ethyl ChlorideAlso: CHLOROETHANE, HYDROCHLORIC ETHER, NDC 45951-0123Spray is to be applied topically to skin (dorsum of the hand for study purposes)until it turns white or for up to 10 seconds. | Drug | ethyl chloride vapocoolant spray |
Primary outcome
Number of children in each group who do not feel pain or have mild pain on propofol injection.
Time frame: Within one hour, plus or minus one half hour
The primary outcome variable is the success/failure of therapy. The therapy is considered a success if a child feels no pain OR has mild pain.
1 secondary outcome
Pain intensity
Time frame: Within one hour, plus or minus one half hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2012.
Related trials for Pain on Propofol IV Injection
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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 N Khalil, M.D. principal investigator
University of Texas Health Sciences Center at 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 (NDC 43469-864-01) and Gebauer's Ethyl Chloride in people with Pain on Propofol IV Injection, 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: status not confirmed, as of the sponsor's last update on 12 Apr 2012. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samia N Khalil, M.D. (713.500.6242, samia.n.khalil@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of children in each group who do not feel pain or have mild pain on propofol injection. (time frame: Within one hour, plus or minus one half hour). 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 12 Apr 2012.