Chronic Respiratory DiseasesPhase 3HOURRANCT07408011
Interest of Cryotherapy in Reducing Pain During Radial Arterial Blood Sampling
A Phase 3 study testing Apllication of medical device ice pack and Apllication of cream in people with Chronic Respiratory Diseases, run by University Hospital, Brest at 2 sites in France.
Trial summary
Arterial puncture for blood gas analysis is a diagnostic procedure used to assess arterial blood gases and monitor a patient's oxygenation status. It is widely regarded by nursing staff as one of the most painful routine procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Respiratory Diseases
- What is being tested?
- Apllication of medical device ice pack and Apllication of cream
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 258 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Nov 2026to 1 Nov 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with a respiratory condition requiring arterial blood gas sampling via radial puncture
- Patients able to assess their pain using a numerical rating scale
- Patients reporting a pain score of 0 on the numerical scale at the wrist prior to sampling
- Patients with no contraindications or allergies to local anesthetics such as lidocaine/prilocaine
- Patients aged 18 years or older
- Patients affiliated with or benefiting from a social security scheme
- Patients able to give consent and who have signed an informed consent form
Who cannot join
- Patients reporting a pain score >0 on the numerical rating scale before sampling
- Emergency context requiring immediate arterial blood gas results
- Patients for whom radial arterial puncture is not feasible
- Known hypersensitivity to local amide-type anesthetics or any component of the lidocaine/prilocaine cream
- Pregnant or breastfeeding women
- Refusal to participate
- Patients under legal guardianship or conservatorship
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
CHU Brest
Brest, Finistere, 29200
Alexandre Fauche, MD, +33 02 98 14 51 62, Alexandre.fauche@chu-brest.fr
CH Morlaix
Morlaix, Finistere, 29672
Catherine Le Ber, MD,PHD, 02 98 62 63 13, cleber@ch-morlaix.fr
About this study
Arterial puncture for blood gas analysis is a diagnostic procedure used to assess arterial blood gases and monitor a patient's oxygenation status. It is widely regarded by nursing staff as one of the most painful routine procedures. Despite this, the use of local anesthesia prior to arterial puncture remains uncommon in clinical practice.
Several types of anesthetic agents and administration techniques have been evaluated, with mixed results regarding their effectiveness in reducing patient-reported pain. Studies comparing subcutaneous lidocaine injection or ethyl chloride spray to no analgesic intervention have shown that ethyl chloride does not significantly reduce pain. Moreover, the discomfort caused by lidocaine injection appears to be comparable to that of the arterial puncture itself, suggesting limited overall benefit from this approach.
Read more
Other investigations have similarly reported a lack of significant pain reduction with ethyl chloride spray, although some contradictory findings exist. Ultrasound-guided arterial puncture has been shown to improve success rates and shorten procedure duration; however, it does not appear to influence pain perception.
The impact of needle size on pain intensity has also been explored, with conflicting results. Some studies found no significant difference in pain when using different gauge needles, while others reported reduced pain with the use of finer needles, such as insulin needles, compared to standard arterial puncture needles.
Topical anesthetic creams combining lidocaine and prilocaine have been assessed in randomized, double-blind trials. These studies found no significant difference between anesthetic and placebo groups in terms of pain intensity or the proportion of painful procedures.
More recently, cryotherapy has been investigated as a non-pharmacological method to reduce pain prior to arterial puncture. Several randomized controlled trials using varying cryotherapy protocols have generally reported a significant reduction in pain compared to control groups, with longer application times appearing to enhance effectiveness.
However, these findings must be interpreted with caution due to methodological limitations. In some studies, sample size calculations were not justified, randomization procedures were poorly described, and reported pain levels were unusually high compared to those typically observed in European populations, raising concerns about external validity. In certain cases, although pain reduction was statistically significant, it did not reach the minimal clinically important difference, limiting its clinical relevance.
Conversely, other trials reported very low pain scores following cryotherapy, suggesting a substantial clinical benefit. The short application time required for cryotherapy also makes it far more practical than topical anesthetic creams, which require prolonged application. This practicality supports its use in both emergency and outpatient settings.
Some authors have noted that blinding is challenging when using cryotherapy and have suggested incorporating placebo interventions in future studies to improve methodological rigor.
Overall, systematic analyses indicate that cryotherapy appears to be a safe and potentially effective method for reducing pain during arterial puncture. Nevertheless, the existing evidence is limited by a high risk of bias, underscoring the need for further high-quality randomized controlled trials.
Conclusion: Given the promising but methodologically constrained evidence, there is a strong justification for conducting a rigorously designed, placebo-controlled randomized trial to accurately assess the effectiveness of cryotherapy in reducing pain associated with radial arterial puncture.
- Conditions
- Chronic Respiratory Diseases
- Being tested
- Apllication of medical device ice pack, Apllication of cream
- Keywords
- Arterial blood gas, Pain, Cryotherapy
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apllication of medical device ice packDevice
Application of a medical device pack during 3 minutes on the area where the arterial blood gas will be performed.
Apllication of creamDrug
Application of a cream 120 min before on the area where the arterial blood gas will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Cryotherapy | Experimental | Application of a medical ice pack on the arm prior to the arterial blood gas procedure Receives: Device: Apllication of medical device ice pack |
| Placebo cream | Placebo comparator | Application of placebo cream on the arm prior the arterial blood gas procedure Receives: Drug: Apllication of cream |
| Anesthetic cream | Active comparator | Application of lidocaine cream on the arm prior arterial blood gas procedure Receives: Drug: Apllication of cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain, measured on a 0-10 numerical rating scale
The Pain experienced during the arterial puncture will be measured with the 0-10 numerical rating scale ( : 0 = no pain, and 10 = the worse pain)
Measured: Periprocedural
Secondary outcomes (9)
Situational anxiety, measured with the STAI-Y state scale
The situational anxiety experienced just before the arterial puncture (i.e. 3 minutes after cryotherapy or 2 hours after cream application) will be measured with the STAI-Y state scale (ranging from 20 to 80, with higher score correlating with greater anxiety)
Measured: 3 minutes after cryotherapy or 2 hours after cream application]
Situational anxiety measured by the heart rate
The situational anxiety experienced just before the arterial puncture (i.e. 3 minutes after cryotherapy or 2 hours after cream application) will be measured by the heart rate in beat per minute with a pulse oxymeter
Measured: 3 minutes after cryotherapy or 2 hours after cream application
Situational anxiety measured by the heart rate
The situational anxiety experienced during the arterial puncture will be measured by the heart rate in beat per minute with a pulse oxymeter
Measured: Periprocedural
Situational anxiety measured by the heart rate
The situational anxiety experienced at the end of the arterial puncture will be measured by the heart rate in beat per minute with a pulse oxymeter
Measured: 1-minute postprocedural
Success of the arterial puncture
The arterial puncture will be measured as a success if the blood sample will be succeeded or as a failure : if the blood sample will be failed
Measured: 1-minute postprocedural
Baseline anxiety measured with the HAD scale
The baseline anxiety will be measured at inclusion with the HAD scale (ranging from 0 to 21 points, with higher score correlating with more severe symptoms)
Measured: Baseline
Time taken to perform the arterial puncture
the time of the blood sample will be noted
Measured: Start and end time of the arterial puncture
Patient satisfaction or perception of the arterial puncture measured with a likert scale
The satisfaction will be assessed after the end of arterial puncture with a likert scale ("Are you satisfied with the care you received during the arterial puncture?: Strongly agree, Agree, Neither agree nor disagree, Disagree, Strongly disagree)
Measured: 3-hour postprocedural
Situational anxiety measured by the heart rate
The situational anxiety experienced at the end of the arterial puncture will be measured by the heart rate in beat per minute with a pulse oxymeter
Measured: Postprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Respiratory DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Model description
- Three arms will be compared using a factorial analysis. First, the intervention group (cryotherapy) will be compared with the placebo cream. Second, if a significant difference is observed for the primary objective, the lidocaine group will be compared with the placebo cream. Third, if a significant difference is observed for the second objective, the lidocaine group will be compared with the intervention group (cryotherapy).
- Masking
- None (open label)
- Enrolment
- 258 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07408011
- Sponsor's protocol ID
- 29BRC23.0052
- Acronym
- HOURRA
- Status last verified
- Oct 2026
- First submitted
- 12 Jan 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Cryotherapy in Reducing Pain During Radial Arterial Blood Sampling
- ClinicalTrials.gov ID
- NCT07408011
- Acronym / sponsor ID
- HOURRA / 29BRC23.0052
- Conditions
- Chronic Respiratory Diseases
- Keywords
- Arterial blood gas, Pain, Cryotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 12 Feb 2026 (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.
Arterial puncture for blood gas analysis is a diagnostic procedure used to assess arterial blood gases and monitor a patient's oxygenation status. It is widely regarded by nursing staff as one of the most painful routine procedures. Despite this, the use of local anesthesia prior to arterial puncture remains uncommon in clinical practice.
Several types of anesthetic agents and administration techniques have been evaluated, with mixed results regarding their effectiveness in reducing patient-reported pain. Studies comparing subcutaneous lidocaine injection or ethyl chloride spray to no analgesic intervention have shown that ethyl chloride does not significantly reduce pain. Moreover, the discomfort caused by lidocaine injection appears to be comparable to that of the arterial puncture itself, suggesting limited overall benefit from this approach.
Other investigations have similarly reported a lack of significant pain reduction with ethyl chloride spray, although some contradictory findings exist. Ultrasound-guided arterial puncture has been shown to improve success rates and shorten procedure duration; however, it does not appear to influence pain perception.
The impact of needle size on pain intensity has also been explored, with conflicting results. Some studies found no significant difference in pain when using different gauge needles, while others reported reduced pain with the use of finer needles, such as insulin needles, compared to standard arterial puncture needles.
Topical anesthetic creams combining lidocaine and prilocaine have been assessed in randomized, double-blind trials. These studies found no significant difference between anesthetic and placebo groups in terms of pain intensity or the proportion of painful procedures.
More recently, cryotherapy has been investigated as a non-pharmacological method to reduce pain prior to arterial puncture. Several randomized controlled trials using varying cryotherapy protocols have generally reported a significant reduction in pain compared to control groups, with longer application times appearing to enhance effectiveness.
However, these findings must be interpreted with caution due to methodological limitations. In some studies, sample size calculations were not justified, randomization procedures were poorly described, and reported pain levels were unusually high compared to those typically observed in European populations, raising concerns about external validity. In certain cases, although pain reduction was statistically significant, it did not reach the minimal clinically important difference, limiting its clinical relevance.
Conversely, other trials reported very low pain scores following cryotherapy, suggesting a substantial clinical benefit. The short application time required for cryotherapy also makes it far more practical than topical anesthetic creams, which require prolonged application. This practicality supports its use in both emergency and outpatient settings.
Some authors have noted that blinding is challenging when using cryotherapy and have suggested incorporating placebo interventions in future studies to improve methodological rigor.
Overall, systematic analyses indicate that cryotherapy appears to be a safe and potentially effective method for reducing pain during arterial puncture. Nevertheless, the existing evidence is limited by a high risk of bias, underscoring the need for further high-quality randomized controlled trials.
Conclusion: Given the promising but methodologically constrained evidence, there is a strong justification for conducting a rigorously designed, placebo-controlled randomized trial to accurately assess the effectiveness of cryotherapy in reducing pain associated with radial arterial puncture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three arms will be compared using a factorial analysis. First, the intervention group (cryotherapy) will be compared with the placebo cream. Second, if a significant difference is observed for the primary objective, the lidocaine group will be compared with the placebo cream. Third, if a significant difference is observed for the second objective, the lidocaine group will be compared with the intervention group (cryotherapy).
| Arm | Type | Receives |
|---|---|---|
| Cryotherapy | Experimental | Device: Apllication of medical device ice packApplication of a medical ice pack on the arm prior to the arterial blood gas procedure |
| Placebo cream | Placebo comparator | Drug: Apllication of creamApplication of placebo cream on the arm prior the arterial blood gas procedure |
| Anesthetic cream | Active comparator | Drug: Apllication of creamApplication of lidocaine cream on the arm prior arterial blood gas procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient with a respiratory condition requiring arterial blood gas sampling via radial puncture
- Patients able to assess their pain using a numerical rating scale
- Patients reporting a pain score of 0 on the numerical scale at the wrist prior to sampling
- Patients with no contraindications or allergies to local anesthetics such as lidocaine/prilocaine
- Patients aged 18 years or older
Key exclusion criteria (7 listed)
- Patients reporting a pain score >0 on the numerical rating scale before sampling
- Emergency context requiring immediate arterial blood gas results
- Patients for whom radial arterial puncture is not feasible
- Known hypersensitivity to local amide-type anesthetics or any component of the lidocaine/prilocaine cream
- Pregnant or breastfeeding women
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 |
|---|---|---|
| Apllication of medical device ice packApplication of a medical device pack during 3 minutes on the area where the arterial blood gas will be performed. | Device | Cryotherapy |
| Apllication of creamApplication of a cream 120 min before on the area where the arterial blood gas will be performed. | Drug | Anesthetic cream, Placebo cream |
Primary outcome
Pain, measured on a 0-10 numerical rating scale
Time frame: Periprocedural
The Pain experienced during the arterial puncture will be measured with the 0-10 numerical rating scale ( : 0 = no pain, and 10 = the worse pain)
9 secondary outcomes
Situational anxiety, measured with the STAI-Y state scale
Time frame: 3 minutes after cryotherapy or 2 hours after cream application]
Situational anxiety measured by the heart rate
Time frame: 3 minutes after cryotherapy or 2 hours after cream application
Situational anxiety measured by the heart rate
Time frame: Periprocedural
Situational anxiety measured by the heart rate
Time frame: 1-minute postprocedural
Success of the arterial puncture
Time frame: 1-minute postprocedural
Baseline anxiety measured with the HAD scale
Time frame: Baseline
Time taken to perform the arterial puncture
Time frame: Start and end time of the arterial puncture
Patient satisfaction or perception of the arterial puncture measured with a likert scale
Time frame: 3-hour postprocedural
Situational anxiety measured by the heart rate
Time frame: Postprocedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Apllication of medical device ice pack and Apllication of cream in people with Chronic Respiratory Diseases, run by University Hospital, Brest at 2 sites in France.
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 7 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: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc Beaumont (+33 02 98 62 61 60 ext. 7750, mbeaumont@ch-morlaix.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain, measured on a 0-10 numerical rating scale (time frame: Periprocedural). 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 30 Oct 2026.