]>
IRCT20200728048242N1 IRCT 2020-08-10 Iran University of Medical Sciences Comparison of intranasal midazolam and ketamine in peripheral IV access in children Comparison of clinical efficacy of Intranasal administration of midazolam and ketamine in managing pain and distress associated with peripheral IV access in children presenting to emergency departments of IUMS 2019-03-21 anticipated 100 Complete https://irct.ir/trial/49960 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The type of drug prescribed is randomized by simple randomization among the participants by using the RRApp software. For this purpose, in the order of participation in the research, the participants will receive midazolam or ketamine based on the group they are assigned by RRApp software. Allocation concealment is not carried out. http://clinicalresearch-apps.com/RRApp.html. 2-3 Pain and distress associated with peripheral IV access in children in emergency department. Intervention 1: Intervention group 1: Intranasal ketamine administration, at a dose of 5 mg/kg from a 50 mg/cc ketamine ampule, produced by Rotexmedica, Germany, twenty minutes before peripheral intravenous access, once via intranasal route, at half the dose in each nostril with a conventional syringe. Intervention 2: Intervention group 2: Intranasal midazolam administration, at a dose of 0.2 mg/kg from a 5 mg/cc midazolam ampule, produced by Darou Paksh pharmaceutical company, twenty minutes before peripheral intravenous access, once via intranasal route, at half the dose in each nostril with a conventional syringe. Yes - There is a plan to make this available What will be shared: Information related to the study protocol, OSBD-R score including four steps, statistics related to the success of the procedure, statistical information and tables and graphs, informed consent form, satisfaction of parents and nurses, information related to heart rate and blood oxygen percentage. When: Starting one year after publication To whom: To anyone whom may benefit from reviewing the information provided, in regard to progressing scientific knowledge Conditions: The use of data by mentioning the source, in case of advancement of scientific knowledge, is unrestricted Where to obtain: Contact the email address regarding data acquisition: imannnehrabi@gmail.com Iman Mehrabi, MD. How to obtain: Send an email stating the reason for the need to access the information Comments:
public Iman Mehrabi
ShahrAra, Arash Mehr st., West Blvd., No 24, Unit 9
Tehran Iran (Islamic Republic of) 1444953541 +98 11 5422 1337 Imannnehrabi@gmail.com Iran University of Medical Sciences scientific Iman Mehrabi
ShahrAra, Arash Mehr st., West Blvd., No 24, Unit 9
Tehran Iran (Islamic Republic of) 1444953541 +98 11 5422 1337 Imannnehrabi@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) 1 to 10 years-old Children Emergency department or wards admission Needing IV access for diagnostic and therapeutic interventions 1 year 10 years Both Patients with critical or emergency conditions, or in other words, have level 1 triage and are treated in the resuscitation room All cases in which parents do not consent to sedation and analgesia prior to peripheral intravenous access All patients with a history of allergies to ketamine or midazolam Age less than one year or over 10 years Existence of serious underlying heart disease including heart failure, electrical heart disorders, congenital heart defects Presence of advanced liver or kidney disease, including renal failure or dialysis, history of kidney or liver transplantation, congenital metabolic disorders Children with cerebral palsy, cystic fibrosis and epilepsy Congenital or acquired jaw and facial abnormalities Other Other Intervention group 1: Intranasal ketamine administration, at a dose of 5 mg/kg from a 50 mg/cc ketamine ampule, produced by Rotexmedica, Germany, twenty minutes before peripheral intravenous access, once via intranasal route, at half the dose in each nostril with a conventional syringe Intervention group 2: Intranasal midazolam administration, at a dose of 0.2 mg/kg from a 5 mg/cc midazolam ampule, produced by Darou Paksh pharmaceutical company, twenty minutes before peripheral intravenous access, once via intranasal route, at half the dose in each nostril with a conventional syringe Observational Scale Of Behavioral distress-Revised Score. Timepoint: 20 min after intervention. Method of measurement: Observational Scale Of Behavioral distress-Revised (OSBD-R). Success rate of accessing peripheral Intravenous line. Timepoint: 20 min after the intervention. Method of measurement: Researcher observation based on the presence or lack of physical restraint during the procedure. Heart Rate. Timepoint: 10 and 20 minutes after the intervention. Method of measurement: Portable Pulse Oximeter. Oxygen Saturation. Timepoint: 10 and 20 minutes after the intervention. Method of measurement: Portable Pulse Oximeter. Satisfaction of parents. Timepoint: Once after the end of the procedure. Method of measurement: 5 point likert scale. Satisfaction of nurses. Timepoint: Once after the end of the procedure. Method of measurement: 5 point likert scale. Iran University of Medical Sciences Approved 2019-07-16 Iran University of Medical Sciences Research Ethics Committee Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences, fifth floor of the headquarters Tehran Tehran Iran (Islamic Republic of)