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IRCT20201204049599N3 IRCT 2021-04-22 Oroumia University of Medical Sciences Assessment of Oxycodone and Mebeverin mixed-effects on colonoscopy quality Assessment of Oxycodone and Mebeverin mixed-effects on colonoscopy quality in patients referring to Urmia Imam Khomeini hospital 2021-04-30 anticipated 125 Complete https://irct.ir/trial/55417 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method is simple randomization. the researcher will divide patients by using table of random numbers. First, each patient will be assigned a three-digit code according to the date and time of the clinic visit. The first patient will have code 001 and the last patient will have code 125. Then in the table of random numbers without looking, a location will be randomly selected. The first two digits will be examined. If the number is less than or equal to 125, it will be selected, otherwise we will continue moving in the direction of the line and other numbers will be checked. If it is a duplicate number, it will be ignored and another number from the table will be checked. We continue this process until 62 codes are selected. The first 62 codes will be for patients in the intervention group (patients who will receive drugs) and the remaining 63 codes will be for the control group (patients who will receive placebo). Thus, patients are randomly divided into two groups, Blinding description: The study will be two-way blind. The patient and the endoscopist will be unaware that the patient belongs to the case or control group. Pills and capsules in the same shape, size and color will be given to patients in both groups. In the intervention group, one oxycodone tablet, which is small and white, and two Mebeverine capsules, which are white, will be given to the patient one hour before colonoscopy by someone other than the endoscopist. In the control group, a vitamin B6 tablet, which is similar in shape, color and size to oxycodone and is completely safe, will be given to the patient one hour before colonoscopy, along with two starch-containing capsules that resemble Mebeverine capsules. 3 colonoscopy. Intervention 1: Intervention group: One hour before colonoscopy, patients in this group will be given 15 mg of oral Oxycodone tablet and 270 mg of oral Mebeverine capsule . Intervention 2: Control group : In the control group, a vitamin B6 tablet, which is similar in shape, color and size to oxycodone and is completely safe, will be given to the patient one hour before colonoscopy, along with two starch-containing capsules that resemble Mebeverine capsules. 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 provided
public Mohammad Reza Pashaee
Imam Khomeini Hospital; Ershad boulevard
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3198 8001 pashaee.m@umsu.ac.ir Oroumia University of Medical Sciences scientific Mohammad Reza Pashaee
Imam Khomeini Hospital; Ershad boulevard
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3198 8001 pashaee.m@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Do not take antispasmodics Suspicion of intestinal polyps bowel diseases Unknown gastrointestinal bleeding 18 years no limit Both Irritable Bowel Syndrome Previous abdominal surgeries Lack of mental health and full consciousness Allergy to oxycodone Allergy to Mebeverine Taking anti-anxiety and painkillers History of allergy to any drug K92.2 Gastrointestinal hemorrhage, unspecified Treatment - Drugs Placebo Intervention group: One hour before colonoscopy, patients in this group will be given 15 mg of oral Oxycodone tablet and 270 mg of oral Mebeverine capsule . Control group : In the control group, a vitamin B6 tablet, which is similar in shape, color and size to oxycodone and is completely safe, will be given to the patient one hour before colonoscopy, along with two starch-containing capsules that resemble Mebeverine capsules. Total procedure time. Timepoint: During endoscopy. Method of measurement: minute, clock. Pain. Timepoint: During endoscopy. Method of measurement: Score based on visual analog scale. Time to reach Cecum. Timepoint: During endoscopy. Method of measurement: minute , clock. Oroumia University of Medical Sciences Approved 2020-09-30 Ethics committee of Urmia University of Medical Sciences Urmia University of Medical Sciences; Resalat boulevard Urmia West Azarbaijan Iran (Islamic Republic of)