Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryotherapy | Experimental | Application of a medical ice pack on the arm prior to the arterial blood gas procedure |
|
| Placebo cream | Placebo Comparator | Application of placebo cream on the arm prior the arterial blood gas procedure |
|
| Anesthetic cream | Active Comparator | Application of lidocaine cream on the arm prior arterial blood gas procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | the pain will be measured with the 0-10 numerical rating scale: 0 = no pain, and 10 = the worse pain | At inclusion |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marc Beaumont | Contact | +33 02 98 62 61 60 | 7750 | mbeaumont@ch-morlaix.fr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Brest | Brest | Finistere | 29200 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
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).
Not provided
Not provided
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.
Not provided
| Apllication of cream | Drug | Application of a cream 120 min before on the area where the arterial blood gas will be performed. |
|
| Compare heart rate before the procedure between groups |
the heart rate will be measured with a pulse oxymeter |
| Before Procedure |
| Compare heart rate during the procedure between groups | heart rate will be measured during the procedure with a pulse- oxymeter | during Procedure |
| Compare heart rate after the procedure between groups | heart rate will be measured at the end of the procedure with a pulse- oxymeter | after Procedure |
| Compare the success rate of the blood samples between groups | if the blood sample will be succeeded: success , if the blood sample is failed : failure | after procedure |
| Evaluate the impact of anxiety on the pain experienced just before the procedure | anxiety will be measured with the STAI-Y just before the procedure | just before procedure |
| Time taken to perform the arterial puncture | the time of the blood sample will be noted | start and end time of the arterial puncture |
| Compare patient satisfaction or perception of the procedure between groups | 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) | end of procedure |
| CH Morlaix | Morlaix | Finistere | 29672 | France |
|