Interest of Cryotherapy in Reducing Pain During Radial Arterial Blood Sampling

NCT07408011 | Not Yet Recruiting Phase 3

• 1 other identifier: 29BRC23.0052
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Chronic Respiratory Diseases

Keywords

Arterial blood gas; Pain; Cryotherapy

Outcome Measures

Primary Outcomes (1)

• pain, measured on a 0-10 numerical rating scale

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

  At inclusion

Secondary Outcomes (8)

• 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)

  At inclusion

• Compare heart rate before the procedure between groups

  Before Procedure

• Compare heart rate during the procedure between groups

  during Procedure

• Compare heart rate after the procedure between groups

  after Procedure

• Compare the success rate of the blood samples between groups

  after procedure

Study Arms (3)

Cryotherapy

EXPERIMENTAL

Application of a medical ice pack on the arm prior to the arterial blood gas procedure

Device: Apllication of medical device ice pack

Placebo cream

PLACEBO COMPARATOR

Application of placebo cream on the arm prior the arterial blood gas procedure

Drug: Apllication of cream

Anesthetic cream

ACTIVE COMPARATOR

Application of lidocaine cream on the arm prior arterial blood gas procedure

Drug: Apllication of cream

Interventions

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.

Cryotherapy

Apllication of cream DRUG

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

Anesthetic cream; Placebo cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (2)

CHU Brest

Brest, Finistere, 29200, France

Location

CH Morlaix

Morlaix, Finistere, 29672, France

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Marc Beaumont

CONTACT

+33 02 98 62 61 60; mbeaumont@ch-morlaix.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study whose primary objective is to compare cryotherapy with placebo cream for pain. However, both the investigator and the patient will be blinded to whether the applied cream is neutral (placebo) or active (lidocaine), making the comparison between lidocaine and placebo double-blind.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: February 12, 2026
• Study Start: February 1, 2026
• Primary Completion: February 1, 2026
• Study Completion (Estimated): November 1, 2029
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

FR (2)