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IRCT20190207042648N3 IRCT 2021-02-16 Mashhad University of Medical Sciences Effect of oral naloxone on constipation of patients treated by opium tincture Double-blind placebo-controlled randomized clinical trial on the use of oral naloxone on constipation of patients treated by opium tincture 2021-05-22 anticipated 120 Complete https://irct.ir/trial/48902 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: In this study 2 doses of Naloxone were compared by placebo, Randomization description: The participants will be divided3 groups by simple individual randomization method. When a patients referred to clinic will be divided into 3 groups by sealed envelops. Physician will treat precipitants according the code in envelope, Blinding description: The patient will be informed that he or she will be given medication or a placebo. Primary Assessors and Consequences (Clinic Physician) are unaware of which patient is receiving what treatment and will evaluate the patient regardless of treatment. Others of the research team know which patients receive which treatment . All drugs that are delivered to patients are in the form of packages with the code and the form of drugs is the same (the drug does not have a specific smell or taste). 3 Drug induced constipation. Intervention 1: Intervention group 1: The blinded therapists of HRCs delivers 7 coded capsules contain 2 mg Naloxan ( Sigma ) after initial evaluation ( for seven days ). The capsuled were filled by faculty of pharmacy of MUMS . The researcher will call to the participants next day to evaluate intolerable opiate withdrawal syndrome. If it is happen, the patient will be excluded. Others will be evaluated at the end of the first week and re-treated for one week again. They will also be evaluated at the end of research. The patients can use their lubricant medications if they need. Intervention 2: Intervention group2: The blinded therapists of HRCs delivers 7 coded capsules contain 4 mg Naloxan ( Sigma ) after initial evaluation ( for seven days ). The capsuled were filled by faculty of pharmacy of MUMS . The researcher will call to the participants next day to evaluate intolerable opiate withdrawal syndrome. If it is happen, the patient will be excluded. Others will be evaluated at the end of the first week and re-treated for one week again. They will also be evaluated at the end of research. The patients can use their lubricant medications if they need. Intervention 3: Control group:: The blinded therapists of HRCs delivers 7 coded capsules contain placebo after initial evaluation ( for seven days ). The capsuled were filled by faculty of pharmacy of MUMS . The researcher will call to the participants next day to evaluate intolerable opiate withdrawal syndrome. If it is happen, the patient will be excluded. Others will be evaluated at the end of the first week and re-treated for one week again. They will also be evaluated at the end of research. The patients can use their lubricant medications if they need. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Mohammad Moshiri
Department of clinical toxicology, Emam Reza Hospital, Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3854 3031 moshirim@mums.ac.ir Mashhad University of Medical Sciences scientific Mohammad Moshiri
Department of clinical toxicology, Emam Reza Hospital, Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3854 3031 Moshirimo@gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Participants that are in the opium tincture treatment in the 5 first months. Willingness to participate in research studies. Receiving the average dose of the opium tincture less than 10 CC in the last month. Age between 20 - 50 years. 20 years 50 years Both Past history of GI surgery History of Thyroid disease History of Diabetes Hypercalcemia Renal failure Using Tricyclic antidepressant Using Calcium Chanel blockers Hypertension Cardiac disease Multi-drugs abuser Using anticholinergic drugs Pregnancy Recently sever weight loss more than 4 NVD or past history of severe labor Parkinsonism K59.0 Constipation Treatment - Drugs Treatment - Drugs Placebo Intervention group 1: The blinded therapists of HRCs delivers 7 coded capsules contain 2 mg Naloxan ( Sigma ) after initial evaluation ( for seven days ). The capsuled were filled by faculty of pharmacy of MUMS . The researcher will call to the participants next day to evaluate intolerable opiate withdrawal syndrome. If it is happen, the patient will be excluded. Others will be evaluated at the end of the first week and re-treated for one week again. They will also be evaluated at the end of research. The patients can use their lubricant medications if they need. Intervention group2: The blinded therapists of HRCs delivers 7 coded capsules contain 4 mg Naloxan ( Sigma ) after initial evaluation ( for seven days ). The capsuled were filled by faculty of pharmacy of MUMS . The researcher will call to the participants next day to evaluate intolerable opiate withdrawal syndrome. If it is happen, the patient will be excluded. Others will be evaluated at the end of the first week and re-treated for one week again. They will also be evaluated at the end of research. The patients can use their lubricant medications if they need. Control group:: The blinded therapists of HRCs delivers 7 coded capsules contain placebo after initial evaluation ( for seven days ). The capsuled were filled by faculty of pharmacy of MUMS . The researcher will call to the participants next day to evaluate intolerable opiate withdrawal syndrome. If it is happen, the patient will be excluded. Others will be evaluated at the end of the first week and re-treated for one week again. They will also be evaluated at the end of research. The patients can use their lubricant medications if they need. Constipation score. Timepoint: At the start of treatment , one and two weeks later (end of research). Method of measurement: CONSTIPATION SCORING SYSTEM and Briston scoring. Defecation in the three areas of abdominal, rectal and feces. Timepoint: At the start of treatment , one and two weeks later (end of research). Method of measurement: PAC-SYM questionnaire. Opiate withdrawal scoring. Timepoint: 24 hours after starting the treatment patients were evaluated by phone call. One and two weeks later ( end of research) were scored. Method of measurement: opiate withdrawal scale. Mashhad University of Medical Sciences Approved 2020-10-27 Ethics committee of Mashhad University of Medical Sciences Gharashi building, Danshghah street Mashhad Razavi Khorasan Iran (Islamic Republic of)