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IRCT20201215049725N1 IRCT 2021-09-10 Karaj University of Medical Sciences Evaluation of Intranasal oxytocine spray effect on preventing post-dural puncture headache after cesarean section Evaluation of Intranasal oxytocine spray effect on preventing post-dural puncture headache after elective cesarean section, A Clinical trial 2021-09-29 anticipated 170 Complete https://irct.ir/trial/53008 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: A randomized list will be generated using block randomization method with non-identical blocks of 2, 4 and 6 in two groups. This list will be generated by the following web address: https://www.sealedenvelope.com/simple-randomiser/v1/lists, Blinding description: For blinding, placebo will be used in the control group which has exact similar appearance with the medicine used in the intervention group. The physician who assess the outcome will not be aware of the patient's groups. 3 post-dural puncture headache. Intervention 1: Intervention group: After cesarean section, The intervention group is given 3-puff (30IU) nasal oxytocin (Alborz Drug Company, Made in Iran) as a single dose immediately after delivery. Intervention 2: Control group: After cesarean section, The Control group is given 3-puff nasal saline, which its appearance is exactly similar to oxytocin, as a single dose immediately after delivery. 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 no more information are available.
public Banafshe Mashak
Kamali Hospital, Kamali St., Shohada Sq., Beheshti St.,
Karaj Iran (Islamic Republic of) 3134877179 +98 26 3222 3021 banafshemashak@abzums.ac.ir Karaj University of Medical Sciences scientific Banafshe Mashak
Kamali Hospital, Kamali St., Shohada Sq., Beheshti St.,
Karaj Iran (Islamic Republic of) 3134877179 +98 26 3222 3021 banafshemashak@abzums.ac.ir Karaj University of Medical Sciences Iran (Islamic Republic of) Elective cesarean candidates no limit no limit Female Allergies to drugs used in this study BMI more than 35 Hepatic, renal or cardiac disorder Neuromuscular disease History of lumbar discopathy / history of neuropathy Opioids or analgesic usage 3 days before the study Consumption of calcium channel blockers O89.4 Spinal and epidural anesthesia-induced headache during the puerperium Prevention Placebo Intervention group: After cesarean section, The intervention group is given 3-puff (30IU) nasal oxytocin (Alborz Drug Company, Made in Iran) as a single dose immediately after delivery. Control group: After cesarean section, The Control group is given 3-puff nasal saline, which its appearance is exactly similar to oxytocin, as a single dose immediately after delivery. Headache severity after spinal anesthesia based on vas-score. Timepoint: 12, 24, 48, 72 hours after cesarean section. Method of measurement: Visual Analogue Scale. Karaj University of Medical Sciences Approved 2021-05-18 Ethics committee of Alborz University of Medical Sciences Unit. 5, No. 32, 20 metri resalat Ave, South Kuye Karmandan town, Karaj Karaj Alborz Iran (Islamic Republic of)