Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07408011

Interest of Cryotherapy in Reducing Pain During Radial Arterial Blood Sampling

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Brest, Brest, Finistere, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Apllication of medical device ice pack

Device

Application of a medical device pack during 3 minutes on the area where the arterial blood gas will be performed.

Apllication of cream

Drug

Application of a cream 120 min before on the area where the arterial blood gas will be performed.

Primary outcomes

  1. pain, measured on a 0-10 numerical rating scale

    Time frame: At inclusion

    Pain will be measured with the 0-10 numerical rating scale : 0 = no pain, and 10 = the worse pain

Secondary outcomes

  1. the pain , measured with the 0-10 numerical rating scale experienced during the puncture (between the use of a cream combining two local anesthetics (lidocaine/prilocaine) and a placebo cream)

    Time frame: At inclusion

    the pain will be measured with the 0-10 numerical rating scale: 0 = no pain, and 10 = the worse pain

  2. Compare heart rate before the procedure between groups

    Time frame: Before Procedure

    the heart rate will be measured with a pulse oxymeter

  3. Compare heart rate during the procedure between groups

    Time frame: during Procedure

    heart rate will be measured during the procedure with a pulse- oxymeter

  4. Compare heart rate after the procedure between groups

    Time frame: after Procedure

    heart rate will be measured at the end of the procedure with a pulse- oxymeter

  5. Compare the success rate of the blood samples between groups

    Time frame: after procedure

    if the blood sample will be succeeded: success , if the blood sample is failed : failure

  6. Evaluate the impact of anxiety on the pain experienced just before the procedure

    Time frame: just before procedure

    anxiety will be measured with the STAI-Y just before the procedure

  7. Time taken to perform the arterial puncture

    Time frame: start and end time of the arterial puncture

    the time of the blood sample will be noted

  8. Compare patient satisfaction or perception of the procedure between groups

    Time frame: end of procedure

    the satisfaction will be assessed with likert scale ("Are you satisfied with the care you received during the blood gas analysis?: Strongly agree, Agree, Neither agree nor disagree, Disagree, Strongly disagree)

Study contacts

Contact information is provided by the study sponsor or research team.

Marc Beaumont

CONTACT

[email protected]

+33 02 98 62 61 60 ext. 7750

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: HOURRA

Important dates

Study start
2026
Primary completion
2026
Study completion
2029
First posted
Feb 12, 2026
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.