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IRCT20210113050021N1 IRCT 2021-02-02 Mashhad University of Medical Sciences Effect of Dexamethasone soaked nasalpack on postoperative pain of patients undergoing Dacryocystorhinostomy surgery Effect of Dexamethasone soaked nasalpack on postoperative pain of patients undergoing Dacryocystorhinostomy surgery 2021-01-09 anticipated 112 Complete https://irct.ir/trial/53709 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple personal randomization will be done using random numbers table and www.randomization.com website. Randomization concealment will be done using closed envelopes. The envelopes will be prepared and printed by one of the members of the research team and random numbers with the help of Randomaization.com and will be placed inside the envelope. The envelopes are closed and the contents cannot be seen from the outside. Then, the purpose of the study will be explained to the person who meets the inclusion criteria and if the person wishes and signs the informed consent form, takes an envelope and then opens it and enters the intervention or control group based on the contents of the envelope, Blinding description: Patients and outcome evaluator are blinded in the trial about how patients are allocated. 3 Lacrimal duct obstruction. Intervention 1: Intervention group: In the intervention group, at the end of the operation, a dexamethasone-impregnated tampon is inserted in the upper horn of the middle conch. Intervention 2: Control group: In the control group, at the end of the operation, a tampon impregnated with normal saline is inserted in the upper horn of the middle concha. Yes - There is a plan to make this available What will be shared: Individual Participant Data Set (IPD): all collected deidentified IPD could be shared. When: Starting 6 months after publication To whom: People working in academic institutions Conditions: No further criteria. Where to obtain: : Khatam al-Anbia Eye Hospital, Aboutaleb Intersection, Mashhad, Iran. 00985137289911 - ocean_jamali@yahoo.com How to obtain: With a reasonable request, the data would be shared via email. Comments:
public Sara Jamali
Khatam Al-Anbia Eye Hospital, Aboutaleb Intersection
Mashhad Iran (Islamic Republic of) 9195965919 +98 51 3728 9911 ocean_jamali@yahoo.com Mashhad University of Medical Sciences scientific Sara Jamali
Khatam Al-Anbia Eye Hospital, Aboutaleb Intersection
Mashhad Iran (Islamic Republic of) 9195965919 +98 51 3728 9911 ocean_jamali@yahoo.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Age between 18 and 75 years old and able to speak Persian, patient candidate for dacryocystorhinostomy surgery, patients with class 1 and 2 anesthesia (ASA), no history of systemic hypertension based on history, no history of known and confirmed Psychological disease based on history, no history of current seizures based on history, no history of alcohol or drug abuse, no use of any painkillers in 24 hours before surgery 18 years 75 years Both H04.559 Acquired stenosis of unspecified nasolacrimal duct Treatment - Drugs Treatment - Drugs Intervention group: In the intervention group, at the end of the operation, a dexamethasone-impregnated tampon is inserted in the upper horn of the middle conch. Control group: In the control group, at the end of the operation, a tampon impregnated with normal saline is inserted in the upper horn of the middle concha. Pain in the first 24 hours after surgery. Timepoint: 0, 3, 6, 12, 18 and 24 hours after surgery. Method of measurement: Pain intensity is assessed by the grading scale used in the NHS system of Wales University Hospital. This scale has 4 degrees: if the patient expresses complete pain relief, the pain intensity is zero and if the patient expresses severe pain, the patient's pain intensity is 3. At this scale, the patient's pain intensity is asked and the patient's description of the pain experienced is marked in one of four categories: "painless, mild, moderate, severe.". Dosage in mg of rescue analgesia (morphine / pethidine / methadone / apotel / ketorolac / indomethacin). Timepoint: 0, 3, 6, 12, 18 and 24 hours after surgery. Method of measurement: questionnaire. The interval between the first use of adjuvant painkillers and the end of the operation. Timepoint: In the first 24 hours after surgery. Method of measurement: Patient statement. Mashhad University of Medical Sciences Approved 2020-11-09 Ethics Committee of Mashhad University of Medical Scienses Mashhad University of Medical Sciences, Azadi Ave., Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)