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IRCT20100202003250N7 IRCT 2024-10-17 Kerman University of Medical Sciences Comparison of the efficiency of methadone and morphine in reducing the Neonatal Abstinence Syndrome born to addicted mothers Comparison of the efficiency of methadone and morphine in reducing the Neonatal Abstinence Syndrome born to addicted mothers 2021-08-23 anticipated 100 Complete https://irct.ir/trial/61902 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization of the unit is done in a block method with a block size of 4. For each of the 6 possible modes for the block of four, the numbers are assigned as follows, ABBA(3), ABAB(2), AABB(1), BAAB(6), BABA(5), BBAA(4) with the help of the table Random numbers, numbers between 1 and 6 are selected and determined according to each number of the treatment allocation list. To implement the generated random sequence, the method of hiding the box or coded cans is used. In this method, the cans are numbered based on a random sequence, and inside the boxes, the intended intervention (medicine) or a sheet with random allocation written on it, provided that the boxes are completely sealed, is provided to the operator. Based on the order of arrival of the patients, the researcher assigns them to the intervention and standard treatment group. Tools: Creating a random sequence of 4 random blocks, concealment will be done to implement the random sequence on the participants of the study. How to build: random selection of blocks and reading letters from right to left, hiding will be done by the method of cans that are numbered based on a random sequence. The cans have the same weight and shape and will be prepared by an independent researcher, Blinding description: Morphine and methadone are placed in two identical bottles of the same color and appearance, the inside of which is unknown, which the clinical caregiver and the nurse are unaware of the type of drug prescribed. 3 Neonatal Abstinence Syndrome. Intervention 1: Intervention group 1 (morphine): In this group, there are 50 patients who are receiving morphine drug treatment. The decision to start drug treatment will be based on the Fingan scoring system. When there is an adequate Fingan standard score (three consecutive Fingan scores greater than 8 or three consecutive Fingan scores greater than 12) for drug treatment, the infant receives the drug under randomized type of drug. In this group, 1 cc of morphine is diluted with 24 cc of distilled water and given to infants. For these infants, the starting dose of treatment will be 0.3-0.2 mg / kg body weight per day divided every 6 hours. The dose of the drug will be evaluated each time based on the score of the Fingan table. If the score of Fingan is higher than 12, the next dose will be added 10% to the dose of the drug, and if the score of Fingan reaches less than 8, the dose of the drug will be reduced again by 10% for the next time. After 48 hours of controlled symptoms (Fingan score between 8 and 12) daily reduced by 10% of the previous maximum dose to below 0.1 mg per kg per day and then morphine will be discontinued. After 48 hours of monitoring, the infant will be discharged. Intervention 2: Intervention group 2 (methadone): There are 50 patients in this group who are receiving methadone drug treatment. The decision to start drug treatment will be based on the Fingan scoring system. When there is an adequate Fingan standard score (three consecutive Fingan scores greater than 8 or three consecutive Fingan scores greater than 12) for drug treatment, the infant receives the drug under study based on a random method of drug type. In this treatment group, the intervention method will be that an oral dose should be given every 6 hours. The starting dose should be 100 µg / kg, each time a higher dose is increased until the symptoms are controlled, increasing to 50 /g / kg every 12 hours. The methadone dose should be reduced by 10 to 20% once a day. After 48 hours of monitoring, the infant will be discharged. 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 Bahareh Bahman Bijari
Afzalipour hospital
Kerman Iran (Islamic Republic of) 7616913355 +98 34 1322 2250 bbbijari@kmu.ac.ir Kerman University of Medical Sciences scientific Bahareh Bahman Bijari
Afzalipour hospital
Kerman Iran (Islamic Republic of) 7616913355 +98 34 1322 2250 bbbijari@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) Infants of mothers who have taken morphine derivatives due to abuse or relief of chronic pain and have been visited at least once or twice for pregnancy care in the third trimester and are able to survive. 1 day 28 days Both Mothers who consume alcohol Congenital and genetic abnormalities. Taking benzodiazepines during pregnancy Infants who are unable to survive or whose survival is in doubt. P96.1 Neonatal withdrawal symptoms from maternal use of drugs of addiction Treatment - Drugs Treatment - Drugs Intervention group 1 (morphine): In this group, there are 50 patients who are receiving morphine drug treatment. The decision to start drug treatment will be based on the Fingan scoring system. When there is an adequate Fingan standard score (three consecutive Fingan scores greater than 8 or three consecutive Fingan scores greater than 12) for drug treatment, the infant receives the drug under randomized type of drug. In this group, 1 cc of morphine is diluted with 24 cc of distilled water and given to infants. For these infants, the starting dose of treatment will be 0.3-0.2 mg / kg body weight per day divided every 6 hours. The dose of the drug will be evaluated each time based on the score of the Fingan table. If the score of Fingan is higher than 12, the next dose will be added 10% to the dose of the drug, and if the score of Fingan reaches less than 8, the dose of the drug will be reduced again by 10% for the next time. After 48 hours of controlled symptoms (Fingan score between 8 and 12) daily reduced by 10% of the previous maximum dose to below 0.1 mg per kg per day and then morphine will be discontinued. After 48 hours of monitoring, the infant will be discharged. Intervention group 2 (methadone): There are 50 patients in this group who are receiving methadone drug treatment. The decision to start drug treatment will be based on the Fingan scoring system. When there is an adequate Fingan standard score (three consecutive Fingan scores greater than 8 or three consecutive Fingan scores greater than 12) for drug treatment, the infant receives the drug under study based on a random method of drug type. In this treatment group, the intervention method will be that an oral dose should be given every 6 hours. The starting dose should be 100 µg / kg, each time a higher dose is increased until the symptoms are controlled, increasing to 50 /g / kg every 12 hours. The methadone dose should be reduced by 10 to 20% once a day. After 48 hours of monitoring, the infant will be discharged. Duration of hospitalization. Timepoint: Duration of hospitalization. Method of measurement: Therapist's observations. Duration of treatment. Timepoint: Duration of hospitalization. Method of measurement: Therapist's observations. Side effects of drugs. Timepoint: Duration of hospitalization. Method of measurement: Therapist's observations. Kerman University of Medical Sciences Approved 2021-09-08 Ethics committee of Kerman University of Medical Sciences Afzalipour Hospital, Next to Shahid Bahonar University, Imam Khomeini Highway کرمان Kerman Iran (Islamic Republic of)