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IRCT20141209020258N136 IRCT 2020-03-13 Arak University of Medical Sciences The effects of Melatonin, Gabapentin and Dextromethorphan on post operative pain control in patients undergoing hip fracture surgery with general anesthesia The effects of Melatonin, Gabapentin and Dextromethorphan on post operative pain control in patients undergoing hip fracture surgery with general anesthesia 2020-01-21 anticipated 120 Complete https://irct.ir/trial/46372 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple individual randomization with randomization with envelopes in 4 groups A and B and C and D . In this method, we selected a number of cards or letters as an intervention group and the same ‎number of cards for the control group, then the cards were merged. One card was taken out and its ‎allocation was registered and the card was returned to the other cards after leaving. Then the cards ‎are merged again and we remove another card. This process continues to reach a random sequence ‎according to sample size, Blinding description: This study is clinical trial.Outcome elevator and analyzer and participant are blind (double blind).Outcome elevator and analyzer and participant don't aware from grouping. 3 Hip fracture surgery. Intervention 1: Intervention group 1: We treat patients with 6 milligram Melatonin sublingual (Webber Natural.Canadian Co.) dissolved in water (final volume is 5 millimeter ) 90 minute before surgery. Intervention 2: Intervention group 2: We treat patients with 1 milligram in kilogram oral Dextromethorphan (Porcina Pharmaceutical Co. Iran)dissolved in water (final volume is 5 millimeter ) 90 minutes before surgery. Intervention 3: Intervention group 3: We treat patients with 600 milligram tablet of Gabapantin (Tehran shimi Co. Iran)dissolved in water (final volume is 5 millimeter ) 90 minutes before surgery. Intervention 4: Control group:We treat patients with 5 millimeter distilled water orally 90 minutes before surgery. Yes - There is a plan to make this available What will be shared: When we publish article in journal When: After the article is published To whom: Researcher in university Conditions: If there are additional questions Where to obtain: Dr Hesamodin Modir How to obtain: They have to write letters to the professors and the university. Comments:
public Dr Behnam Mahmodie
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 mahmodie@arakmu.ac.ir Arak University of Medical Sciences scientific Dr Hesamedin Modir
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 modir.he@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Candidate for hip fracture surgery 17 to 65 years old Both sexes Absence of fractures in other organs Absence of coagulation disorders Lack of renal and hepatic and cardiovascular disease No history of drug use in the past 48 hours No drug and psychotropic addiction and alcohol 17 years 65 years Both Unwillingness to participate in the study Severe hemodynamic instability S32.4 Fracture of acetabulum Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: We treat patients with 6 milligram Melatonin sublingual (Webber Natural.Canadian Co.) dissolved in water (final volume is 5 millimeter ) 90 minute before surgery. Intervention group 2: We treat patients with 1 milligram in kilogram oral Dextromethorphan (Porcina Pharmaceutical Co. Iran)dissolved in water (final volume is 5 millimeter ) 90 minutes before surgery. Intervention group 3: We treat patients with 600 milligram tablet of Gabapantin (Tehran shimi Co. Iran)dissolved in water (final volume is 5 millimeter ) 90 minutes before surgery. Control group:We treat patients with 5 millimeter distilled water orally 90 minutes before surgery. Pain. Timepoint: At recovery time, 2, 4, 6, 12 and 24 hours after surgery. Method of measurement: Visual analog scale. Sedation. Timepoint: 24 hours after surgery. Method of measurement: Ramsy score. Mean of opiate drug. Timepoint: 24 hours after surgery. Method of measurement: Milligram. Mean blood pressure. Timepoint: Every 15 minutes during surgery and recovery time. Method of measurement: Barometer. Mean heart rate. Timepoint: Every 15 minutes during surgery and recovery time. Method of measurement: Count. Arak University of Medical Sciences Approved 2020-01-12 Ethics Committee Of Arak University Of Medical Sciences Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak Arak Markazi Iran (Islamic Republic of)