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IRCT20200429047244N2 IRCT 2022-02-02 University of Baghdad Using Cryotherapy, EMLA Cream, and Lidocaine Spray to Reduce Pain during Arteriovenous Fistula Puncture: A Randomized Clinical Trial Comparison the effectiveness of Cryotherapy, EMLA Cream, and Lidocaine Spray to Reduce Pain during Arteriovenous Fistula Puncture among clients undergoing hemodialysis 2022-02-01 anticipated 86 Complete https://irct.ir/trial/61456 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: A simple randomization sampling method will be used to assign the study sample in four groups: ice pack, EMLA cream, lidocaine spray, and a control group. Simple randomization is an appropriate method to be used in this clinical trial to increase the probability and reduce and bias. A sealed envelope contained four colors (red, blue, green, and yellow) will be given to each client to choose one color. The clients were allocated to groups based on their colors; red= control, blue= ice pack, green= EMLA cream, and yellow= lidocaine spray. Indeed, four groups will be allocated randomly. 3 Arteriovenous Fistula in End-stage Renal Failure. Intervention 1: Intervention group1: 5 cubs of ice (4 × 2 × 2 cm) will be placed in a plastic bag and covered with a layer of cotton cloth for five minutes on the site of AVF. Then, the area will be disinfected by 70% alcohol pads before the AVF puncture. After that, the needle will be inserted by the ward nurse, and the pain will be assessed immediately after the needle insertion. Intervention 2: Intervention group2: 1.5 g of EMLA cream (Lidocaine 25 mg and Prilocaine 25 mg, Recipharm Karlskoga) will be applied to six cm2 on the area of AVF for 20 minutes before the AVF puncture. After that, the EMLA cream will be removed, and the area will be disinfected by 70% alcohol pads. Then, the needle will be inserted by the ward nurse, and the pain will be assessed immediately after the needle insertion. Intervention 3: Intervention group3: three sprinklings of lidocaine spray (ElQady, Ankara, Turkey) will be sprayed on the AVF. After five minutes (Bhalla et al., 2009), the area will be disinfected by 70% alcohol pads. Then, the needle will be inserted by the ward nurse, and the pain will be assessed immediately after the needle insertion. Intervention 4: Control group: no procedures will be done before AVF puncture, and the pain will be assessed immediately after the needle insertion. Yes - There is a plan to make this available What will be shared: The data will be the results of Visual Analogue Scale that measure clients' pain during AVF puncture in both control and interventions groups. When: If the article is published in an open access journal, the data will be available after 6 months of publication. If the article is published in a subscribed journal, the data will be available after one year because of the policy of the subscribed journals. To whom: With academic nurses and any researcher who is interested in the data Conditions: The data could be used after getting the authors' permission via email. Also, users need to acknowledge the owner. Where to obtain: Users can ask for the data and the permission via email. Dr. Al-Jubouri is the corresponding author. He will be in contact with whom ask for the data. His email is maaljubouri@conursing.uobaghdad.edu.iq Also, Dr. Al-Jubouri works at University of Baghdad/ College of Nursing. The address is Bab Al-Muadham, Baghdad, Iraq. How to obtain: Users can ask for the data and the permission via email. Dr. Al-Jubouri is the corresponding author. He will be in contact with whom ask for the data. His email is maaljubouri@conursing.uobaghdad.edu.iq Comments:
public Mohammed Baqer Al-Jubouri
Al-Adhamia, Al-Keriaat
Baghdad Iraq 10053 +964 1 489 6875 maaljubouri@conursing.uobaghdad.edu.iq University of Baghdad scientific Mohammed Baqer Al-Jubouri
Al-Adhamia, Al-Keriaat
Baghdad Iraq 10053 +964 1 489 6875 maaljubouri@conursing.uobaghdad.edu.iq University of Baghdad Iraq Iraq Iraq Iraq Iraq Iraq Iraq clients with more than 18 years old being under hemodialysis at least for three months being conscious and alert be able to sign the written informed consent 18 years no limit Both clients who are cold intolerance clients who have allergy from local anesthetics or topical medications Clients who have upper extremities paralysis pregnant or lactating females I28.0 Arteriovenous fistula of pulmonary vessels Treatment - Other Treatment - Drugs Treatment - Drugs N/A Intervention group1: 5 cubs of ice (4 × 2 × 2 cm) will be placed in a plastic bag and covered with a layer of cotton cloth for five minutes on the site of AVF. Then, the area will be disinfected by 70% alcohol pads before the AVF puncture. After that, the needle will be inserted by the ward nurse, and the pain will be assessed immediately after the needle insertion. Intervention group2: 1.5 g of EMLA cream (Lidocaine 25 mg and Prilocaine 25 mg, Recipharm Karlskoga) will be applied to six cm2 on the area of AVF for 20 minutes before the AVF puncture. After that, the EMLA cream will be removed, and the area will be disinfected by 70% alcohol pads. Then, the needle will be inserted by the ward nurse, and the pain will be assessed immediately after the needle insertion. Intervention group3: three sprinklings of lidocaine spray (ElQady, Ankara, Turkey) will be sprayed on the AVF. After five minutes (Bhalla et al., 2009), the area will be disinfected by 70% alcohol pads. Then, the needle will be inserted by the ward nurse, and the pain will be assessed immediately after the needle insertion. Control group: no procedures will be done before AVF puncture, and the pain will be assessed immediately after the needle insertion. Pain during arteriovenous fistula puncture in clients undergoing hemodialysis. Timepoint: Immediately after the arteriovenous fistula puncture. Method of measurement: Visual Analogue Scale is a measurement tool that will be used to assess clients' pain. The author himself is the funding source. Approved 2022-01-23 Ethics committee in College of Nursing at University of Baghdad Bab-AlMuadham Baghdad Baghdad Iraq