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IRCT20220128053852N2 IRCT 2023-03-04 Esfahan University of Medical Sciences Procedural pain and anxiety in children Comparison of the effectiveness of intranasal Midazolam, oral Melatonin and distraction method in reducing stress and pain caused by intravenous cannulation in children 3 to 10 years old 2022-05-22 anticipated 120 Complete https://irct.ir/trial/61714 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: we will use blocked randomsation. Using the Random Allocation software 2, for 4 study groups, 15 blocks of 8 were calculated for a sample size of 120 people, each person will be identified with a unique code (consisting of two letters and a Latin number). To assign the child to each of the 4 study groups, an envelope containing a unique code and treatment group will be delivered to the child's parents. The project associate nurse, who is stationed next to the nurse responsible for venipuncture, will open the envelope and specify the type of intervention before starting the venipuncture, Blinding description: In this study, the nurse who performs the venipuncture also applies the analgesic method to the child. The nurse who records clinical signs before and after venipuncture is unaware of the type of analgesia applied. The same nurse also gives the child the scale of pain that the child is supposed to grade. The film that is to be taken from the child's facial expressions will be taken by the pediatric resident, but the pain and anxiety will be scored by the presenter and the project partner separately and based on the film. However, both of them are not aware of the type of painless intervention in the patient who will be graded. 3 Procedural pain and anxiety in children. Intervention 1: Control group: 3 to 10 year olds need venipuncture for which no intervention is applied. Intervention 2: Intervention group 1:Melatonin drug under the brand name Nem Life is given to the child at a dose of half a milligram per kilogram of the child's body weight and a maximum of 5 mg orally, 30 minutes before venipunctur. Intervention 3: Intervention group 2: Midazolam ampoule with a dose of two tenths of a milligram per kilogram of body weight and a total volume of half a cc is used intranasally 15 minutes before inserting the intravenous line and once for the child. After administering the medicine in the nose, the nostril is kept closed for 30 seconds. Midazolam ampoule is produced by Kimidaro factory and is 5 mg. Intervention 4: Intervention group 3: Use of in-house distraction cards modeled after similar cards from Buzzy UK which are shown to the child 3 minutes before the venipuncture, and the co-nurse asks the child the questions on the back of the picture card that are related to the pictures and their details to distract her. Yes - There is a plan to make this available What will be shared: All data except videos taken from a potential child can be shared after unidentified individuals. When: 6 months after publishing the results To whom: Researchers working in academic and scientific institutions Conditions: For academic use by faculty members of universities in the country and around the world Where to obtain: Email to Dr. Minoo Saeidi at minoo.saeidi@gmail.com How to obtain: My email address is minoo.saeidi@gmail.com Comments:
public Minoo Saeidi
Imam Khomeini Ave, Imam Hossein Children Hospital
Isfahan Iran (Islamic Republic of) 8195163381 +98 31 3386 6266 minoo.saeidi@gmail.com Esfahan University of Medical Sciences scientific Minoo Saeidi
Imam Khomeini Ave
Isfahan Iran (Islamic Republic of) 8195163381 +98 31 3386 6266 minoo.saeidi@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Parental consent No urgent need for venipuncture 3 to 10 years old childs 3 years 10 years Both Hearing and vision disorders that prevent the child from interacting Dissatisfaction of parents to continue the study at any time during the intervention Chronic or acute use of a sedative drug The child has been taking painkillers, even acetaminophen, for the last 6 hours Symptoms of a child's airway disorder Patients with American Society of Anesthesiologists ’(ASA) classification from grade 3 upwards Urgent need for venipuncture including decreased level of consciousness, shocks, severe respiratory distress, uncontrolled seizures, arrhythmia Children at high risk for aspiration such as gastroesophageal reflux disease or gastrointestinal motility disorders Y84.9 Medical procedure, unspecified as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure Prevention Treatment - Drugs Treatment - Drugs Treatment - Other Control group: 3 to 10 year olds need venipuncture for which no intervention is applied Intervention group 1:Melatonin drug under the brand name Nem Life is given to the child at a dose of half a milligram per kilogram of the child's body weight and a maximum of 5 mg orally, 30 minutes before venipunctur Intervention group 2: Midazolam ampoule with a dose of two tenths of a milligram per kilogram of body weight and a total volume of half a cc is used intranasally 15 minutes before inserting the intravenous line and once for the child. After administering the medicine in the nose, the nostril is kept closed for 30 seconds. Midazolam ampoule is produced by Kimidaro factory and is 5 mg. Intervention group 3: Use of in-house distraction cards modeled after similar cards from Buzzy UK which are shown to the child 3 minutes before the venipuncture, and the co-nurse asks the child the questions on the back of the picture card that are related to the pictures and their details to distract her. Pain caused by intravenous line insertion. Timepoint: Determining pain score during and after venipuncture. Method of measurement: Face, Legs, Activity, Cry, Consolability scale and Visual analogue scale. Child anxiety. Timepoint: Child's stress before and during intravenous line insertion. Method of measurement: Children's Emotional Manifestation Scale. Esfahan University of Medical Sciences Approved 2021-12-19 Ethics committee of Isfahan University of Medical Sciences Isfahan, Imam Khomeini Ave, Imam hossein children university hospital Isfahan Isfehan Iran (Islamic Republic of)