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IRCT20120613010017N7 IRCT 2018-06-17 Iran University of Medical Sciences Effect of ketamine intranasal in ease of access to peripheral veins Effect of ketamine intranasal with placebo in ease of access to peripheral veins and reduce child pain 2018-04-24 anticipated 80 Complete https://irct.ir/trial/30411 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants in the study will be assigned to two groups using a block randomization method, Blinding description: Participants in the study will be blinded of the type of received intervention. Physicians assessing the clinical conditions of participants will be blinded of the type of intervention received by patients. 3 Easy venipuncture in all children that venipuncture is needed in the process of treatment. Intervention 1: Intervention group: Before doing venipuncture, intranasal ketamine will be given with a dose of 4 miligeram per Kilograms body weight and according to the half-life and the maximum effect time of the drug will be taken venipuncture 5 minutes later. Intervention 2: Control group: Intranasal Normal Saline will be prescribed in the form of spray before venipuncture doing. After 5 minutes venipuncture will be taken. 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 decision has yet been taken In this question with other colleagues.
public Hamed Basir Ghafouri
Rasoul Akram hospital, Niyayesh St, Sattar Khan St.
Tehran Iran (Islamic Republic of) ۱۴۴۵۶۱۳۱۳۱ +98 21 6653 9233 Basirghafoori.h@iums.ac.ir Iran University of Medical Sciences scientific Hamed Basir Ghafouri
Rasoul Akram hospital, Niyayesh St, Sattar Khan St.
Tehran Iran (Islamic Republic of) ۱۴۴۵۶۱۳۱۳۱ +98 21 6653 9233 Basirghafoori.h@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Children aged 6 months to 6 years in an emergency needing to venipuncture 6 months 6 years Both Unwell children Intense Dehydration Having a history of allergy to ketamine Seizure Having brain lesions Increased intracranial pressure Treatment - Drugs Placebo Intervention group: Before doing venipuncture, intranasal ketamine will be given with a dose of 4 miligeram per Kilograms body weight and according to the half-life and the maximum effect time of the drug will be taken venipuncture 5 minutes later. Control group: Intranasal Normal Saline will be prescribed in the form of spray before venipuncture doing. After 5 minutes venipuncture will be taken. Success in venipuncture. Timepoint: Count the insert needle. Method of measurement: Count. Duration in successful venipuncture. Timepoint: Duration from start to end of successful venipuncture. Method of measurement: Observe. Patient pain. Timepoint: End of venipuncture. Method of measurement: Using Visual Analogue Scale for pain measurement. Iran University of Medical Sciences Approved 2018-06-12 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemmat Highway, Tehran Tehran Tehran Iran (Islamic Republic of)