Puncture Site PainNCT01860248
Vapocoolant Spray Effectiveness On Arterial Puncture Pain: Randomized Double Blind Placebo-Controlled Trial
A study testing Vapocoolant spray and Water spray in people with Puncture Site Pain, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
This study was aimed to compare pain levels from arterial blood gas (ABG) sampling performed with vapocoolant spray in comparison to placebo. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Puncture Site Pain
- What is being tested?
- Vapocoolant spray and Water spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteIran
- Study dates
- May 2012to Jun 2013
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age of 14 years or older,
- needs ABG as a part of their diagnosis
Who cannot join
- history of analgesic medication used within 24 hours of enrollment,
- any sign of decreased consciousness,
- history of skin hypersensitivity,
- inability to report a pain score,
- history of a known neurological problem that changes pain perception,
- history of cold related reactions (e.g. Raynaud's phenomenon, cold urticaria),
- abnormal Allen's test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Topical Alkane Vapocoolant Spray Effectiveness On Arterial Puncture Pain Reduction In Emergency Department: Randomized Double Blind Placebo-Controlled Trial
This study was aimed to compare pain levels from arterial blood gas (ABG) sampling performed with vapocoolant spray in comparison to placebo.
Read the detailed description
Previous studies of vapocoolant sprays for reducing pain were mainly on venopuncture with inconsistent results. There was only one prospective open labeled controlled study on arterial blood gas sampling with ethyl chloride which did not show effectiveness. This study will assess the efficacy and tolerability of a topical alkane vapocoolant spray for arterial puncture in adults in comparison to control spray.
- Conditions
- Puncture Site Pain
- Being tested
- Vapocoolant spray, Water spray
- Keywords
- vapocoolant effectiveness, arterial puncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vapocoolant sprayDrug
Also called Cryoanesthetic
The Vapocoolant spray containing alkane is applied for 20 seconds.
Water sprayDrug
This spray is covered so the patient and the investigator can not find the spray type out.
| Study group | Role | What they receive |
|---|---|---|
| Vapocoolant spray | Experimental | Vapocoolant is administered in 20 centimeters distance for 20 seconds to the patients as anesthetic before ABG. Receives: Drug: Vapocoolant spray |
| Water spray | Placebo comparator | The Patients in this arm will receive water spray as anesthetic before ABG. Receives: Drug: Water spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
puncture pain
30 seconds after ABG was performed, the patients would be asked about the puncture pain in verbal numerical pain scale.
Measured: 30 seconds after ABG
Secondary outcomes (2)
Vapocoolant application pain
30 seconds after ABG was performed, the patients would be asked about the spray application pain in verbal numerical pain scale.
Measured: 30 seconds affter procedure completion
number of puncture attempts
The number of ABG sampling attempts is recorded 30 seconds after procedure.
Measured: 30 seconds after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2013 (estimated)
- Study startMay 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Puncture Site 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shervin Farahmand, M.D., Principal investigator, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01860248
- Sponsor's protocol ID
- TUMS 4341
- Status last verified
- Jul 2013
- First submitted
- 7 May 2013
- Last updated
- 17 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Alkane Vapocoolant Spray Effectiveness On Arterial Puncture Pain Reduction In Emergency Department: Randomized Double Blind Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT01860248
- Acronym / sponsor ID
- TUMS 4341
- Conditions
- Puncture Site Pain
- Keywords
- vapocoolant effectiveness, arterial puncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 22 May 2013 (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.
This study was aimed to compare pain levels from arterial blood gas (ABG) sampling performed with vapocoolant spray in comparison to placebo.
Detailed description
Previous studies of vapocoolant sprays for reducing pain were mainly on venopuncture with inconsistent results. There was only one prospective open labeled controlled study on arterial blood gas sampling with ethyl chloride which did not show effectiveness. This study will assess the efficacy and tolerability of a topical alkane vapocoolant spray for arterial puncture in adults in comparison to control spray.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vapocoolant spray | Experimental | Drug: Vapocoolant sprayVapocoolant is administered in 20 centimeters distance for 20 seconds to the patients as anesthetic before ABG. |
| Water spray | Placebo comparator | Drug: Water sprayThe Patients in this arm will receive water spray as anesthetic before ABG. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- age of 14 years or older,
- needs ABG as a part of their diagnosis
Key exclusion criteria (7 listed)
- history of analgesic medication used within 24 hours of enrollment,
- any sign of decreased consciousness,
- history of skin hypersensitivity,
- inability to report a pain score,
- history of a known neurological problem that changes pain perception,
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 sprayAlso: CryoanestheticThe Vapocoolant spray containing alkane is applied for 20 seconds. | Drug | Vapocoolant spray |
| Water sprayThis spray is covered so the patient and the investigator can not find the spray type out. | Drug | Water spray |
Primary outcome
puncture pain
Time frame: 30 seconds after ABG
30 seconds after ABG was performed, the patients would be asked about the puncture pain in verbal numerical pain scale.
2 secondary outcomes
Vapocoolant application pain
Time frame: 30 seconds affter procedure completion
number of puncture attempts
Time frame: 30 seconds after 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 17 Jul 2013.
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.
Shervin Farahmand, M.D. principal investigator
Tehran University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vapocoolant spray and Water spray in people with Puncture Site 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 2 inclusion and 7 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 17 Jul 2013. 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. 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?
puncture pain (time frame: 30 seconds after ABG). 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 17 Jul 2013.