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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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

Other trials in France

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.

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 groups in NCT07408011
Study groupRoleWhat they receive
CryotherapyExperimentalApplication of a medical ice pack on the arm prior to the arterial blood gas procedure
Receives: Device: Apllication of medical device ice pack
Placebo creamPlacebo comparatorApplication of placebo cream on the arm prior the arterial blood gas procedure
Receives: Drug: Apllication of cream
Anesthetic creamActive comparatorApplication 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.

  1. 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)
  1. 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]

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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.

  1. First posted12 Feb 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion1 Nov 2028 (estimated)
  4. Study completion1 Nov 2028 (estimated)

Resources

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)
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

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.

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