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IRCT20220812055665N1 IRCT 2022-11-28 Gorgan University of Medical Sciences The effect of oral melatonin in reduction pain during venipuncture _a double blind clinical trial The effect of oral melatonin in reduction pain during venipuncture _a double blind clinical trial 2022-11-06 anticipated 202 Complete https://irct.ir/trial/66025 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method and tool: In this study, we will use the restricted randomization method of the block randomization type. Blocking is usually used in order to create a balance in the number of samples allocated to each of the studied groups. This feature helps researchers to ensure that the number of samples allocated to each of the study groups is equal in cases where intermediate analyzes are needed during the sampling process. The total size of the blocks is equal and in this trial we will have two groups of 6 blocks including 3 participants in the intervention group and 3 participants in the control group. The randomization tool is also used from random allocation software, which, in addition to simple randomization, is capable of generating random sequences using the block method, Blinding description: Concealment: We will use allocation concealment. By using opaque letter envelopes sealed with a random sequence, in this method, each of the generated random sequences is recorded on a card and the cards are placed inside the letter envelopes in order. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of starting the registration of participants, based on the order in which eligible participants entered the study, one of the envelopes will be opened and the assigned group of that participant will be revealed. Double masked blind Both patients and all researchers related to patients are unaware of the patient's perceived exposure. The patient can be identified with a code that is placed in an envelope, and in another place it is clear whether this number is a medicine or a placebo. 3 Pain during venipuncture. Intervention 1: Intervention group: This group includes children to reduce pain and restlessness during venipuncture, melatonin drug will be used for them before venipuncture, and then the success of this method will be evaluated. This group includes 3 to 6 year old children receiving melatonin medication, who receive a single dose of 0.5 mg/kg and a maximum dose of 5 mg 30 to 60 minutes before venipuncture. The melatonin tablet is from jalinous company and has a dose of 5 mg, which is dissolved in 5 cc of water by a trained nurse before use and is given to the child with the mentioned dose. Older children can take the medicine in pill form. After 30 to 60 minutes, venipuncture will be done, and during venipuncture, the child's reactions will be evaluated based on the flacc criteria. Intervention 2: Control group: This group includes children to reduce pain and restlessness during venipuncture, melatonin placebo will be used for them before venipuncture, and then the success of this method will be evaluated. This group includes children aged 3 to 6 years who receive a single dose of placebo with a dose of 0.5 mg/kg and a maximum dose of 5 mg 30 to 60 minutes before venipuncture. The melatonin placebo is from jalinuos company and is completely similar to the 5 mg melatonin tablet. The placebo is dissolved in 5 cc of water by a trained nurse and given to the child with the mentioned dose. Older children can take the medicine in the form of tablets with the correct dosage. After 30 to 60 minutes, venipuncture will be done, and during venipuncture, the child's reactions will be evaluated based on the flacc criteria. No - There is not a plan to make this available Justification or reason for not sharing IPD is preservation of personal information
public Zohre Akbari jokar
15 Golara, 8 golshahr, golshahr blvd, gorgan
Gorgan Iran (Islamic Republic of) 4916984654 +98 17 3252 2711 Zohreakbari2351@yahoo.com Gorgan University of Medical Sciences scientific Zohre Akbari Jokar
15 Golara, 8 golshahr, golshahr blvd, gorgan
Gorgan Iran (Islamic Republic of) 4916984654 +98 17 3252 0369 zohreakbari2351@yahoo.com Gorgan University of Medical Sciences Iran (Islamic Republic of) children with 3-6 y reffered to Taleghani Hospital Parental consent for the child to participate in the study need to venipuncture for intravenous infusion 3 years 6 years Both loss of consciousness acute and life threatening state any psychological disorder ( autism , ADHD) any reaction to melatonin use any sedative or pain relief drug emergency state G89.18 Other acute postprocedural pain N/A N/A Intervention group: This group includes children to reduce pain and restlessness during venipuncture, melatonin drug will be used for them before venipuncture, and then the success of this method will be evaluated. This group includes 3 to 6 year old children receiving melatonin medication, who receive a single dose of 0.5 mg/kg and a maximum dose of 5 mg 30 to 60 minutes before venipuncture. The melatonin tablet is from jalinous company and has a dose of 5 mg, which is dissolved in 5 cc of water by a trained nurse before use and is given to the child with the mentioned dose. Older children can take the medicine in pill form. After 30 to 60 minutes, venipuncture will be done, and during venipuncture, the child's reactions will be evaluated based on the flacc criteria. Control group: This group includes children to reduce pain and restlessness during venipuncture, melatonin placebo will be used for them before venipuncture, and then the success of this method will be evaluated. This group includes children aged 3 to 6 years who receive a single dose of placebo with a dose of 0.5 mg/kg and a maximum dose of 5 mg 30 to 60 minutes before venipuncture. The melatonin placebo is from jalinuos company and is completely similar to the 5 mg melatonin tablet. The placebo is dissolved in 5 cc of water by a trained nurse and given to the child with the mentioned dose. Older children can take the medicine in the form of tablets with the correct dosage. After 30 to 60 minutes, venipuncture will be done, and during venipuncture, the child's reactions will be evaluated based on the flacc criteria. Pain score is primary outcome. Timepoint: 30 to 60 min after drug consumption. Method of measurement: FLACC score ( measurement changes of face,legs,activity,cry,consolability). Secondary outcome is anxiety. Timepoint: 30-60 min after drug consumption. Method of measurement: observation. Success in venipuncture. Timepoint: 30-60 min after drug consumption. Method of measurement: observation. Child cooperation. Timepoint: 30-60 min after drug consumption. Method of measurement: observation. Gorgan University of Medical Sciences Approved 2022-10-16 Ethics committee of Golestan University of medical science Hirkan Blvd Gorgan Golestan Iran (Islamic Republic of)