PainPhase 3NCT04473820
Comparison of Lidocaine-Prilocaine Combination and Vapocoolant for IV Cannulation Pain in the ED
A Phase 3 study testing Vapocoolant spray and Lidocaine-Prilocaine cream in people with Pain, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
Hypothesis: Lidocaine-Prilocaine Combination is as effective as Vapocoolant in treating IV cannulation pain in the emergency department. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain
- What is being tested?
- Vapocoolant spray and Lidocaine-Prilocaine cream
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteIran
- Study dates
- 16 Feb 2024to 31 May 2024
- Phase
- Phase 3
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Low acute patients who are waiting for the admission to the ED and require IV cannulation
Who cannot join
- Altered mental status
- Uncooperative patients
- Unable to communicate
- Known history of hypersensitivity reaction to cold or amid analgesics
- Analgesic usage in previous 6 hours
- No consent
- Emergent condition
- Pregnancy and lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of The Efficacy of Lidocaine-Prilocaine Combination and Vapocoolant Spray to Reduce Pain of IV Cannulation in The Emergency Department: A Randomized Clinical Trial
Hypothesis: Lidocaine-Prilocaine Combination is as effective as Vapocoolant in treating IV cannulation pain in the emergency department.
Read the detailed description
Lidocain-Prilocaine combination cream is two amide-type local anesthetics used for topical skin anesthesia. Vapocoolant spray is also another method for providing appropriate analgesia through crayoanesthetic mechanisms. Although there are some contraindications and adverse effects, these are widely used in the Emergency Department (ED) for IV cannulation pain.
- Conditions
- Pain
- Being tested
- Vapocoolant spray, Lidocaine-Prilocaine cream
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vapocoolant sprayDrug
The spray will be applied continuously from 25 cm distance for less than 5 seconds to the cannulation site.
Lidocaine-Prilocaine creamDrug
A finger tip (0.5 gr) of the cream will be applied in 4 square cm at cannulation site and will be covered with closed dressing for 45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Vapocoolant spray | Active comparator | Patients in this arm will receive vapocoolant spray before IV cannulation. Receives: Drug: Vapocoolant spray |
| Lidocaine-Prilocaine cream | Active comparator | Patients in this arm will receive Lidocaine-Prilocaine cream before IV cannulation. Receives: Drug: Lidocaine-Prilocaine cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cannulation pain: numerical rating score (NRS)
The numerical rating score (NRS) will be used for the study. The NRS ranges from 0 (no pain) to 10 (very severe pain). The higher the pain scores the higher the pain severity. The pain severity will be asked from the patients.
Measured: immediately after the procedure.
Secondary outcomes (2)
Application pain: numerical rating score (NRS)
The numerical rating score (NRS) will be used for the study. The NRS ranges from 0 (no pain) to 10 (very severe pain). The higher the pain scores the higher the pain severity. The pain severity will be asked from the patients.
Measured: immediately after the procedure.
Catheterization attempts
Number of times the direction of IV catheter is changed before the successful cannulation. Exit from the skin is also considered an attempt.
Measured: immediately after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start16 Feb 2024
- Primary completion29 Apr 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadi Mirfazaelian, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04473820
- Sponsor's protocol ID
- 9111215292
- Status last verified
- May 2024
- First submitted
- 10 Jul 2020
- Last updated
- 4 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akhgar A, Mazidabadi Farahani A, Akbari H, Sedaghat M, Jalili M, Mirfazaelian H. Comparison of the effects of vapocoolant spray and topical anaesthetic cream (lidocaine-prilocaine) on pain of intravenous cannulation: a randomised controlled trial. Emerg Med J. 2025 May 22;42(6):373-377. doi: 10.1136/emermed-2024-214479.
PubMed 40118519
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of The Efficacy of Lidocaine-Prilocaine Combination and Vapocoolant Spray to Reduce Pain of IV Cannulation in The Emergency Department: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04473820
- Acronym / sponsor ID
- 9111215292
- Conditions
- Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- 16 Feb 2024 (actual)
- Primary completion
- 29 Apr 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 16 Jul 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.
Hypothesis: Lidocaine-Prilocaine Combination is as effective as Vapocoolant in treating IV cannulation pain in the emergency department.
Detailed description
Lidocain-Prilocaine combination cream is two amide-type local anesthetics used for topical skin anesthesia. Vapocoolant spray is also another method for providing appropriate analgesia through crayoanesthetic mechanisms. Although there are some contraindications and adverse effects, these are widely used in the Emergency Department (ED) for IV cannulation pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vapocoolant spray | Active comparator | Drug: Vapocoolant sprayPatients in this arm will receive vapocoolant spray before IV cannulation. |
| Lidocaine-Prilocaine cream | Active comparator | Drug: Lidocaine-Prilocaine creamPatients in this arm will receive Lidocaine-Prilocaine cream before IV cannulation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Low acute patients who are waiting for the admission to the ED and require IV cannulation
Key exclusion criteria (8 listed)
- Altered mental status
- Uncooperative patients
- Unable to communicate
- Known history of hypersensitivity reaction to cold or amid analgesics
- Analgesic usage in previous 6 hours
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 |
|---|---|---|
| Vapocoolant sprayThe spray will be applied continuously from 25 cm distance for less than 5 seconds to the cannulation site. | Drug | Vapocoolant spray |
| Lidocaine-Prilocaine creamA finger tip (0.5 gr) of the cream will be applied in 4 square cm at cannulation site and will be covered with closed dressing for 45 minutes. | Drug | Lidocaine-Prilocaine cream |
Primary outcome
Cannulation pain: numerical rating score (NRS)
Time frame: immediately after the procedure.
The numerical rating score (NRS) will be used for the study. The NRS ranges from 0 (no pain) to 10 (very severe pain). The higher the pain scores the higher the pain severity. The pain severity will be asked from the patients.
2 secondary outcomes
Application pain: numerical rating score (NRS)
Time frame: immediately after the procedure.
Catheterization attempts
Time frame: immediately after the procedure.
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 4 Jun 2024.
- Derived from this study: PubMed 40118519Akhgar A, Mazidabadi Farahani A, Akbari H, Sedaghat M, Jalili M, Mirfazaelian H. Comparison of the effects of vapocoolant spray and topical anaesthetic cream (lidocaine-prilocaine) on pain of intravenous cannulation: a randomised controlled trial. Emerg Med J. 2025 May 22;42(6):373-377. doi: 10.1136/emermed-2024-214479.
- Individual participant dataSharing planned: No
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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 Phase 3 study testing Vapocoolant spray and Lidocaine-Prilocaine cream in people with Pain, run by Tehran University of Medical Sciences at 1 site in Iran.
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 1 inclusion and 8 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 4 Jun 2024. 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 Iran. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Cannulation pain: numerical rating score (NRS) (time frame: immediately after the procedure.). 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 NCT04473820, which also lists 1 linked publication.
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 4 Jun 2024.