]>
IRCT20180826040868N1 IRCT 2018-09-15 Bojnourd University of Medical Sciences Effectiveness of vapocoolant spray versus lidocaine spray on vascular needle pain Comparing the effectiveness of vapocoolant spray versus lidocaine spray on pain intensity due to insertion of vascular needles in hemodialysis patients 2018-09-23 anticipated 45 Complete https://irct.ir/trial/33500 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Supportive, Randomization description: All patients undergoing hemodialysis with inclusion criteria are randomly assigned to three intervention groups. First, ABCs, BACs, ACBs, BCAs, CABs, CBAs, and CABs are considered and from zero to five number are allocated to each block, respectively (A vapocoolant spray group, B lidocaine sprays group, C placebo spray group). Then, from the random number table, the number of random samples according to sample size in each group is selected, after deleting the numbers from 6 to 9, is assigned to each corresponding block number. Then numbered and according to the list, patients are assigned to one of three groups, Blinding description: Participants blinding (patients) and clinical caregiver: To prepare placebo sprays, we will empty the lid of lidocaine spray dish and spill it into it. The outer part of each of the three sprays is covered with paper to have an almost identical appearance. Outcome evaluator blinding: In all cases, the coolaborator applies the spray to the skin of the patients and the question of pain score is performed by the executor without notice of the type of spray used. When applying sprays, the executor is not present at the patient's bedside. 3 Venous access pain. Intervention 1: Intervention group: Each of the samples in the next dialysis session (two days later) randomly receives one of the following interventions: a vapocoolant spray, 10% lidocaine spray and a placebo spray. Samples who first received a vapocoolant spray (two days later From the initial needle that was without any intervention), two weeks later, lidocaine sprays and four weeks later receive placebo spray. Patients who first receive lidocaine spray receive a vapocoolant spray two weeks after the lidocaine spray, placebo spray, and four weeks after the lidocaine spray, and patients who received the first placebo, two weeks later, a vapocoolant spray and four weeks Lidocaine spray is then applied to the skin. Intervention 2: Control group: Since the study design is cross-over, each patient is considered to be a control group and receives a placebo spray. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Sima Sadat Hejazi
Shahriar Street
Bojnurd Iran (Islamic Republic of) 9417696786 +98 58 3229 7096 s.hejazi@nkums.ac.ir Bojnourd University of Medical Sciences scientific Sima Sadat Hejazi
Shahriar Street
Bojnurd Iran (Islamic Republic of) 94176-96786 +98 58 3229 7096 s.hejazi@nkums.ac.ir Bojnourd University of Medical Sciences Iran (Islamic Republic of) GCS 15 Ability to speak and understand Farsi or having Persian language translator Not have pacemaker Not have Known cardiac disease Start hemodialysis at least 3 months ago Not have Known reaction to lidocaine Products Not have damaged skin Not analgesic use in the last 24 hours Not use of the cream or products lidocaine in the past Hemodialysis via arteriovenous fistula Not anti arrhythmic medications use (especially Class 3 for example Amiodarone) Perform dialysis three times a week age more than 18 age less than 80 18 years 80 years Both Skin reaction or abnormal response in arteriovenous fistula site Absence to perform hemodialysis Failure in vascular access by first try at any of the stages G89 Pain, not elsewhere classified Prevention Prevention Intervention group: Each of the samples in the next dialysis session (two days later) randomly receives one of the following interventions: a vapocoolant spray, 10% lidocaine spray and a placebo spray. Samples who first received a vapocoolant spray (two days later From the initial needle that was without any intervention), two weeks later, lidocaine sprays and four weeks later receive placebo spray. Patients who first receive lidocaine spray receive a vapocoolant spray two weeks after the lidocaine spray, placebo spray, and four weeks after the lidocaine spray, and patients who received the first placebo, two weeks later, a vapocoolant spray and four weeks Lidocaine spray is then applied to the skin. Control group: Since the study design is cross-over, each patient is considered to be a control group and receives a placebo spray. Pain score. Timepoint: At the beginning of study, two days after, two weeks after the first intervention, four weeks after the first intervention and six weeks after the first intervention. Method of measurement: Numerical Rating Scale. Bojnourd University of Medical Sciences Approved 2018-06-24 Ethics committee of North Khorasan University of Medical Sciences Shahriar Street Bojnurd North Khorasan Iran (Islamic Republic of)