Pain SyndromeNCT04555980
Warm Patch Decrease Propofol Injection Pain
A study testing Warming patch and Cotton patch in people with Pain Syndrome and Propofol Infusion Syndrome, run by First People's Hospital of Chenzhou at 1 site in China.
Trial summary
Propofol causes injection pain is still a common clinical unsolved problem. Mixing a small amount of lidocaine with propofol or injecting lidocaine in advance can reduce the pain caused by propofol injection. Using an air warmer to warm the arm can also reduce the pain caused by propofol injection. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Pain Syndrome, Propofol Infusion Syndrome, Injection Site Irritation
- What is being tested?
- Warming patch and Cotton patch
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2020to 6 Sep 2020
- Phase
- Interventional
- 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- No peripheral phlebitis
- No history of Raynaud's syndrome
- No history of smoking or alcoholism
- Body mass index BMI<28 kg/cm2
Who cannot join
- Refusal of anesthesia
- Previous injection pain caused by propofol
- Difficulty in exposing the veins on the back of the hand or difficulty in venipuncture
- Complained of pain after normal saline infusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Will Warm Patch on the Injecting Site Decrease the Injection Pain Induced by Propofol
Propofol causes injection pain is still a common clinical unsolved problem. Mixing a small amount of lidocaine with propofol or injecting lidocaine in advance can reduce the pain caused by propofol injection. Using an air warmer to warm the arm can also reduce the pain caused by propofol injection. Investors suspect that treatment with a warming patch (covering the injection site) can also reduce the pain caused by propofol injection.
Read the detailed description
This is a single-center randomized controlled clinical study. Purpose of this study is to explore whether the coverage of the warming patch (for 5min before injection) can reduce the pain induced by propofol injection.
The patients included in the study were randomly divided into two groups. The group W used a warming patch to cover the injection site, and the group C used a cotton pad to cover the injection site. After 5 minutes of coverage, the propofol injection was induced, and the patient's complaint of pain (calling or arm withdrawal) during propofol injection was observed, and the patient's recall of the pain score during induction after the patient recovered. After the patients regained consciousness, the data of the two groups were compared to determine whether the use of the warming patch could reduce the pain caused by propofol injection.
- Being tested
- Warming patch, Cotton patch
- Keywords
- propofol,injection,pain
- Medical subject headings
- Somatoform Disorders, Propofol Infusion Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warming patchDevice
The warming patch can increase the temp of injection site, result in a blood vessels to dilate, which may have some contribute to decreasing injection pain.
Cotton patchDevice
The Cotton patch will cover the injection site as placebo. It dose not have the function of heating comparing to Warming patch.
| Study group | Role | What they receive |
|---|---|---|
| Warm patch | Experimental | the injection site was covered with warm patch. Receives: Device: Warming patch |
| Cotton patch | Placebo comparator | the injection site was covered with cotton patch. Receives: Device: Cotton patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arm withdrawn
When propofol was injected, the arm was withdrawn due to injection pain.
Measured: 5min
Complaints of pain
The patient complained about the pain of the propofol injection
Measured: 5min
Pain score after awakening from propofol
Let the patients give a score when they recoved from propofol induced anesthesia.
Measured: 10min
Secondary outcomes (2)
Respiratory depression
those ases when pulse oxygen saturation is less than 90%
Measured: 5min
Temperature of injection site after injecting of propofol.
Get the temperature of the back of the hand with an infrared thermometer
Measured: 10min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start20 Mar 2020
- Primary completion1 Sep 2020
- Study completion6 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pain SyndromeStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group W : the injection site was covered with warm patch. Group C: the injection site was covered with Cotton patch.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Chenzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zhiming zhang, First People's Hospital of Chenzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555980
- Sponsor's protocol ID
- 202001
- Status last verified
- Sep 2020
- First submitted
- 8 Sep 2020
- Last updated
- 21 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Jeong M, Yoon H. Comparison of the effects of lidocaine pre-administration and local warming of the intravenous access site on propofol injection pain: Randomized, double-blind controlled trial. Int J Nurs Stud. 2016 Sep;61:209-18. doi: 10.1016/j.ijnurstu.2016.06.012. Epub 2016 Jun 24.
PubMed 27372434Euasobhon P, Dej-Arkom S, Siriussawakul A, Muangman S, Sriraj W, Pattanittum P, Lumbiganon P. Lidocaine for reducing propofol-induced pain on induction of anaesthesia in adults. Cochrane Database Syst Rev. 2016 Feb 18;2(2):CD007874. doi: 10.1002/14651858.CD007874.pub2.
PubMed 26888026Lang BC, Yang CS, Zhang LL, Zhang WS, Fu YZ. Efficacy of lidocaine on preventing incidence and severity of pain associated with propofol using in pediatric patients: A PRISMA-compliant meta-analysis of randomized controlled trials. Medicine (Baltimore). 2017 Mar;96(11):e6320. doi: 10.1097/MD.0000000000006320.
PubMed 28296748
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Will Warm Patch on the Injecting Site Decrease the Injection Pain Induced by Propofol
- ClinicalTrials.gov ID
- NCT04555980
- Acronym / sponsor ID
- 202001
- Keywords
- propofol,injection,pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- First People's Hospital of ChenzhouUniversity, hospital or other
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 6 Sep 2020 (actual)
- First posted
- 21 Sep 2020 (actual)
- 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.
Propofol causes injection pain is still a common clinical unsolved problem. Mixing a small amount of lidocaine with propofol or injecting lidocaine in advance can reduce the pain caused by propofol injection. Using an air warmer to warm the arm can also reduce the pain caused by propofol injection. Investors suspect that treatment with a warming patch (covering the injection site) can also reduce the pain caused by propofol injection.
Detailed description
This is a single-center randomized controlled clinical study. Purpose of this study is to explore whether the coverage of the warming patch (for 5min before injection) can reduce the pain induced by propofol injection.
The patients included in the study were randomly divided into two groups. The group W used a warming patch to cover the injection site, and the group C used a cotton pad to cover the injection site. After 5 minutes of coverage, the propofol injection was induced, and the patient's complaint of pain (calling or arm withdrawal) during propofol injection was observed, and the patient's recall of the pain score during induction after the patient recovered. After the patients regained consciousness, the data of the two groups were compared to determine whether the use of the warming patch could reduce the pain caused by propofol injection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Group W : the injection site was covered with warm patch. Group C: the injection site was covered with Cotton patch.
| Arm | Type | Receives |
|---|---|---|
| Warm patch | Experimental | Device: Warming patchthe injection site was covered with warm patch. |
| Cotton patch | Placebo comparator | Device: Cotton patchthe injection site was covered with cotton patch. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- No peripheral phlebitis
- No history of Raynaud's syndrome
- No history of smoking or alcoholism
- Body mass index BMI<28 kg/cm2
Key exclusion criteria (4 listed)
- Refusal of anesthesia
- Previous injection pain caused by propofol
- Difficulty in exposing the veins on the back of the hand or difficulty in venipuncture
- Complained of pain after normal saline infusion.
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 |
|---|---|---|
| Warming patchThe warming patch can increase the temp of injection site, result in a blood vessels to dilate, which may have some contribute to decreasing injection pain. | Device | Warm patch |
| Cotton patchThe Cotton patch will cover the injection site as placebo. It dose not have the function of heating comparing to Warming patch. | Device | Cotton patch |
Primary outcome
Arm withdrawn
Time frame: 5min
When propofol was injected, the arm was withdrawn due to injection pain.
Complaints of pain
Time frame: 5min
The patient complained about the pain of the propofol injection
Pain score after awakening from propofol
Time frame: 10min
Let the patients give a score when they recoved from propofol induced anesthesia.
2 secondary outcomes
Respiratory depression
Time frame: 5min
Temperature of injection site after injecting of propofol.
Time frame: 10min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2020.
- Background: PubMed 27372434Jeong M, Yoon H. Comparison of the effects of lidocaine pre-administration and local warming of the intravenous access site on propofol injection pain: Randomized, double-blind controlled trial. Int J Nurs Stud. 2016 Sep;61:209-18. doi: 10.1016/j.ijnurstu.2016.06.012. Epub 2016 Jun 24.
- Background: PubMed 26888026Euasobhon P, Dej-Arkom S, Siriussawakul A, Muangman S, Sriraj W, Pattanittum P, Lumbiganon P. Lidocaine for reducing propofol-induced pain on induction of anaesthesia in adults. Cochrane Database Syst Rev. 2016 Feb 18;2(2):CD007874. doi: 10.1002/14651858.CD007874.pub2.
- Background: PubMed 28296748Lang BC, Yang CS, Zhang LL, Zhang WS, Fu YZ. Efficacy of lidocaine on preventing incidence and severity of pain associated with propofol using in pediatric patients: A PRISMA-compliant meta-analysis of randomized controlled trials. Medicine (Baltimore). 2017 Mar;96(11):e6320. doi: 10.1097/MD.0000000000006320.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warming patch and Cotton patch in people with Pain Syndrome and Propofol Infusion Syndrome, run by First People's Hospital of Chenzhou at 1 site in China.
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 4 inclusion and 4 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 21 Sep 2020. 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 China. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Arm withdrawn (time frame: 5min). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04555980, which also lists 3 linked publications.
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 21 Sep 2020.