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IRCT20260613069778N1 IRCT 2026-06-15 Tehran University of Medical Sciences Time-Dependent Analgesic Efficacy of Topical Vapocoolant Spray for Venipuncture Pain: A Comparative Study of Two Application Intervals A Comparative Study of the Time-Dependent Effectiveness of Topical cold analgesic (Vapocoolant ) spray on Venipuncture Pain: Measurements at Two Time Intervals After Application 2026-06-22 anticipated 46 Complete https://irct.ir/trial/90838 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random Sequence Generation: The allocation sequence will be generated by a statistician who has no role in the recruitment and intervention process, using the Block Randomization method with variable block sizes of 4 and 6, and with the help of the online software www.randomization.com. Allocation Concealment: The generated allocation sequence will be placed in opaque, serialized envelopes. Bioequivalence Venipuncture pain in patients requiring peripheral venous catheterization in the emergency department. Intervention 1: Intervention group: The Vipoculant spray containing chloroethane (brand: Power Deltazex). The venipuncture site in the antecubital fossa will be determined by the collaborating nurse. Prior to administering the spray, the nurse is given the opportunity to select the appropriate venipuncture site and rate the ease of access of this site on a scale of 1 to 5. The venipuncture site will first be disinfected with an alcohol pad, and then the spray will be immediately applied by the intervention officer from a distance of 15 cm for 2 seconds onto the venipuncture site. Venipuncture will be performed within 60 seconds after spray administration, and the pain resulting from venipuncture will be measured and recorded by an evaluator (researcher) using the NRS scale. Venipuncture will be performed by an experienced nurse to reduce the likelihood of first-attempt failure. However, three attempts (needle redirections) are considered a failure. It is expected that within the mentioned time frame, success or failure in venipuncture (as defined above) will occur. If for any reason (e.g., difficult venipuncture) the time of needle insertion exceeds the specified window, that patient will be excluded from the final analysis and replaced with a new patient to maintain group homogeneity. Intervention 2: Comparator group: Vipoculant spray containing chloroethane (brand: Power Deltazex). The venipuncture site in the antecubital fossa will be determined by the collaborating nurse. Prior to administering the spray, the nurse is given the opportunity to select the appropriate venipuncture site and rate the ease of access of this site on a scale of 1 to 5. The venipuncture site will first be disinfected with an alcohol pad, and then the spray will be immediately applied by the intervention officer from a distance of 15 cm for 2 seconds onto the venipuncture site. Venipuncture will be performed 5 to 6 minutes after spray administration, and the pain resulting from venipuncture will be measured and recorded by an evaluator using the NRS scale. Venipuncture will be performed by an experienced nurse to reduce the likelihood of first-attempt failure. However, three attempts (needle redirections) are considered a failure. It is expected that within the aforementioned time frame, success or failure in venipuncture (as defined above) will occur. If for any reason (e.g., difficult venipuncture) the time of needle insertion exceeds the specified window, that patient will be excluded from the final analysis and replaced with a new patient to maintain group homogeneity. Yes - There is a plan to make this available What will be shared: Unique title of the shared data document: "Individual participant data from the clinical trial on time‑dependent effectiveness of vapocoolant spray on venipuncture pain" After publication of the main results, all fully de‑identified individual participant data (coded with no personally identifiable information such as name, surname, or phone number) will be available for sharing with other researchers. These data include demographic information (age, sex), medical history, analgesic use history, baseline pain score, post‑venipuncture pain score (primary outcome), adverse events, number of venipuncture attempts, venipuncture success, and patient satisfaction (all primary and secondary outcomes). A data dictionary (variable guide) will accompany the dataset. Access will be granted upon reasonable request to the corresponding author (Dr. Atousa Akhgar) after signing a Data Use Agreement. When: The data sharing period will commence six months after the publication of the primary results of the study in a peer‑reviewed scientific journal. This interval is intended to ensure completion of all planned analyses and fair use of the data by the primary research team. De‑identified individual participant data will remain available to qualified researchers for up to five years following the publication date. To whom: Eligible requestors include researchers affiliated with academic institutions, hospitals, and scientific research centers (both public and private). Researchers working in the pharmaceutical or medical device industry may also request access, provided their request is accompanied by a valid research question approved by an independent ethics committee. In all cases, the applicant must submit a clear research proposal and sign a Data Use Agreement ensuring that data will be used only for the approved purpose and that no attempts will be made to re-identify participants. Access for purely commercial purposes (without a documented research question) is not permitted. Conditions: Access to de-identified individual participant data requires submission of an IRB-approved research proposal. Data may only be used for approved, non-commercial analyses. Any attempt to re-identify participants is strictly forbidden. Publications must cite the original source. Data access is granted for a maximum of 12 months, after which all copies must be deleted. Applicants must comply with applicable data protection laws, sign a Data Use Agreement, and provide a final report of findings to the primary research team. Where to obtain: Access will be granted upon reasonable request to the corresponding author (Dr. Atousa Akhgar) via email after signing a Data Use Agreement. How to obtain: Access will be granted upon reasonable request to the corresponding author (Dr. Atousa Akhgar) via email after signing a Data Use Agreement. Comments:
public Atousa Akhgar
Imam Khomeini hospital., Keshavarz blvd.
Tehran Iran (Islamic Republic of) ۱۴۱۹۷۳۳۱۴۱ +98 912 337 9584 at.akhgar@gmail.com Tehran University of Medical Sciences scientific Atousa Akhgar
Imam Khomeini hospital., Keshavarz blvd,
Tehran Iran (Islamic Republic of) ۱۴۱۹۷۳۳۱۴۱ +98 912 337 9584 at.akhgar@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) _ Age group 18 to 65 years (excluding children and the elderly due to the possible impact of psychological factors on the perception of pain) _ Having a full level of consciousness (GCS = 15) and the mental and verbal ability to understand instructions and report pain using the NRS scale _ Providing written informed consent to participate in the study. - Patients for whom the antecubital region has been selected by the nurse as the first venipuncture site 18 years 65 years Both - People with acute or chronic diseases affecting pain perception _ Presence of any active skin disease, injury or abnormality in the area to be tested _ Known history of allergy to chloroethan or other vapocollants_ Known neuropathic diseases or neurological diseases that make the person unable to perceive pain or chronic pain syndromes_ Use of nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids or other analgesics in the 4 to 72 hours before the test_ Use of caffeine or nicotine in the 8 hours before the test_ Pregnancy or breastfeeding.- Failure of antecubital venipuncture by the nurse and selection of another site for venipuncture_ Patients requiring urgent venipuncture and triage level 2 or higher such as having severe underlying pain (pain greater than 7 out of 10) and unstable vital signs. Treatment - Devices Treatment - Devices Intervention group: The Vipoculant spray containing chloroethane (brand: Power Deltazex). The venipuncture site in the antecubital fossa will be determined by the collaborating nurse. Prior to administering the spray, the nurse is given the opportunity to select the appropriate venipuncture site and rate the ease of access of this site on a scale of 1 to 5. The venipuncture site will first be disinfected with an alcohol pad, and then the spray will be immediately applied by the intervention officer from a distance of 15 cm for 2 seconds onto the venipuncture site. Venipuncture will be performed within 60 seconds after spray administration, and the pain resulting from venipuncture will be measured and recorded by an evaluator (researcher) using the NRS scale. Venipuncture will be performed by an experienced nurse to reduce the likelihood of first-attempt failure. However, three attempts (needle redirections) are considered a failure. It is expected that within the mentioned time frame, success or failure in venipuncture (as defined above) will occur. If for any reason (e.g., difficult venipuncture) the time of needle insertion exceeds the specified window, that patient will be excluded from the final analysis and replaced with a new patient to maintain group homogeneity. Comparator group: Vipoculant spray containing chloroethane (brand: Power Deltazex). The venipuncture site in the antecubital fossa will be determined by the collaborating nurse. Prior to administering the spray, the nurse is given the opportunity to select the appropriate venipuncture site and rate the ease of access of this site on a scale of 1 to 5. The venipuncture site will first be disinfected with an alcohol pad, and then the spray will be immediately applied by the intervention officer from a distance of 15 cm for 2 seconds onto the venipuncture site. Venipuncture will be performed 5 to 6 minutes after spray administration, and the pain resulting from venipuncture will be measured and recorded by an evaluator using the NRS scale. Venipuncture will be performed by an experienced nurse to reduce the likelihood of first-attempt failure. However, three attempts (needle redirections) are considered a failure. It is expected that within the aforementioned time frame, success or failure in venipuncture (as defined above) will occur. If for any reason (e.g., difficult venipuncture) the time of needle insertion exceeds the specified window, that patient will be excluded from the final analysis and replaced with a new patient to maintain group homogeneity. Pain score immediately after venipuncture in the group receiving vapocoolant spray at 30–60 seconds post-application, measured by the Numerical Rating Scale (NRS) from 0 (no pain) to 10 (worst possible pain). Timepoint: Pain score (NRS) is measured at two time points: first, baseline pain is measured before spray application (for both groups). Second, pain is measured immediately after venipuncture, which occurs at 30–60 seconds post-spray for group 1 and at 5–6 minutes post-spray for group 2. Therefore, the primary outcome (venipuncture pain) is measured at a single time point for each participant, immediately after the procedure, within the allocated interval. Method of measurement: The measurement tool for the primary outcome is the Numerical Rating Scale (NRS) for pain, which is an eleven-point scale ranging from 0 (no pain) to 10 (worst possible pain). This scale is verbally explained by the outcome assessor to the participant, and the patient's response is recorded as a single integer from 0 to 10. Pain score immediately after venipuncture in the group receiving vapocoolant spray at 5–6 minutes post-application, measured by the Numerical Rating Scale (NRS) from 0 (no pain) to 10 (worst possible pain). Timepoint: Pain score (NRS) is measured at two time points: first, baseline pain is measured before spray application (for both groups). Second, pain is measured immediately after venipuncture, which occurs at 30–60 seconds post-spray for group 1 and at 5–6 minutes post-spray for group 2. Therefore, the primary outcome (venipuncture pain) is measured at a single time point for each participant, immediately after the procedure, within the allocated interval. Method of measurement: The measurement tool for the primary outcome is the Numerical Rating Scale (NRS) for pain, which is an eleven-point scale ranging from 0 (no pain) to 10 (worst possible pain). This scale is verbally explained by the outcome assessor to the participant, and the patient's response is recorded as a single integer from 0 to 10. Occurrence of local adverse events including erythema, burning sensation, or allergic reaction at the spray application site. Timepoint: Up to one hour after spray application. Method of measurement: Direct observation by the researcher and verbal report by the participant. Successful venipuncture from the same antecubital area where the spray was applied. Timepoint: Immediately after the venipuncture attempt, within the time interval allocated to the group. Method of measurement: Recording the proportion of successful attempts (needle enters the vein without changing site) versus unsuccessful attempts (inability to cannulate from that site). Number of attempts for venipuncture from the sprayed site. Timepoint: During the venipuncture procedure, within the allocated time interval. Method of measurement: Counting the number of needle insertions into the skin (maximum three attempts; needle redirection without complete withdrawal is counted as a new attempt). Overall participant satisfaction with the pain relief method using vapocoolant spray. Timepoint: End of the study, immediately after recording the venipuncture pain score. Method of measurement: Three-point Likert scale including options of "low satisfaction", "moderate satisfaction", and "high satisfaction", asked verbally from the participant. Tehran University of Medical Sciences Approved 2026-06-01 Ethics committee of Tehran University of Medical Sciences Imam Khomeini Hospital., Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)