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IRCT20111010007752N13 IRCT 2022-10-14 Babol University of Medical Sciences Analgesic effect of oral oxycodone and intravenous fentanyl in patients undergoing colonoscopy Comparison of analgesic effects of oral oxycodone and intravenous fentanyl in patients undergoing lower gastrointestinal colonoscopy 2022-10-02 anticipated 80 Complete https://irct.ir/trial/65968 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization will be done using permuted blocks of size 4. (AABB) in such a way that blocks of 4 consist of random combinations of 2 A (Oxycodone) and 2 B (Fentanyl). It will be allocated to two groups of 40 people. Creating a random sequence in the blocks will be done by a statistician, Blinding description: Oxycodone is in capsule form. For the purpose of blinding, capsules containing placebo are chosen to be the same shape as oxycodone capsules, so that they are completely similar in terms of smell, color and shape. Capsules containing oxycodone and placebo are placed in cans of the same shape and size, and then a code will be written on each can. After the patient enters the study, one of these cans will be assigned to the patient and the code on the can will be written on the patient's file (study checklist), while the researcher does not know the contents of the can and the codes. Opening the codes will be done after completing the study. 3 Acute pain. Intervention 1: Intervention group: Patients receive slow-release oral oxycodone (Faroxi company) with a dose of 30 mg one hour before the start of the colonoscopy, then after one hour they enter the room, and after monitoring and 5 minutes before the start of the colonoscopy, 1 cc Normal saline intravenous saline is prescribed. Intervention 2: Control group: patients receive placebo capsules one hour before the start of colonoscopy, then enter the room after one hour, and after entering the room and monitoring, they receive 50 micrograms of intravenous fentanyl (Caspian) (1 cc). No - There is not a plan to make this available Justification or reason for not sharing IPD is There is still no plan for its publish
public Parviz Amri
Ayatollah Rouhani Hospital, Daneshgah Square, Ganjafrooz Avenue
Babol Iran (Islamic Republic of) 47176-41367 +98 11 3233 8301 p.amrimaleh@mubabol.ac.ir Babol University of Medical Sciences scientific Parviz Amri
Ayatollah Rouhani Hospital, Daneshgah Square, Ganjafrooz Avenue
Babol Iran (Islamic Republic of) 47176-41367 +98 11 3233 8301 p.amrimaleh@mubabol.ac.ir Babol University of Medical Sciences Iran (Islamic Republic of) The American Society of Anesthesiologists (ASA) class I&II (Grade 1: No cardiovascular, respiratory, glandular and Grade 2: Controlled diabetes) Age 18-69 years old Colonoscopy candidate Consent to participate in the study 18 years 69 years Both Decreased level of consciousness GCS less than 15 History of drug addiction Hemodynamic instability Mental disorders G89.18 Other acute postprocedural pain Treatment - Drugs Treatment - Drugs Intervention group: Patients receive slow-release oral oxycodone (Faroxi company) with a dose of 30 mg one hour before the start of the colonoscopy, then after one hour they enter the room, and after monitoring and 5 minutes before the start of the colonoscopy, 1 cc Normal saline intravenous saline is prescribed. Control group: patients receive placebo capsules one hour before the start of colonoscopy, then enter the room after one hour, and after entering the room and monitoring, they receive 50 micrograms of intravenous fentanyl (Caspian) (1 cc). Intensity of pain. Timepoint: during colonoscopy. Method of measurement: visual analog scale. Babol University of Medical Sciences Approved 2022-08-15 Ethics Committee of Babol University of Medical Siences Daneshgah Square, Ganjafrooz Avenue Babol Mazandaran Iran (Islamic Republic of)