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IRCT20210314050703N2 IRCT 2021-06-15 Sanandaj University of Medical Sciences Comparing Effect of Gabapentin and Caffeine on Treatment of Headache Following Spinal Anesthesia Comparing Effect of Gabapentin and Caffeine on Treatment of Headache Following Spinal Anesthesia in Women Candidate for Cesarean Section 2021-06-22 anticipated 80 Complete https://irct.ir/trial/56341 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are assigned to one of the intervention and control groups by block randomization method. In this method, how to randomize people to each of the intervention groups, the formation of 4 random blocks is used for randomization. The letter A is for group 1 (gabapentin) and the letter B is for group 2 (caffeine). The order of letters in each block is as follows. AABB, ABAB, ABBA, BBAA, BABA, BAAB Patients are assigned to one of the study groups based on the letters in each randomly selected block, Blinding description: Patients do not know which study groups they will be in. Also, the nurse in the study provides the medication to the patients and is not aware of the patient's grouping. He/She also does not know which medication giving to the patient. Medications are coded by a nurse who does not participate in the study and provides the medication to the prescribing nurse based on the code. Also, the nurse who collects and records patient information does not know which group the patient belongs to. 3 Post dural puncture headache. Intervention 1: Intervention group 1: Administration of 300 mg capsule of gabapentin(Mehr Darou- Tehran- Iran) orally every 12 hours for 3 days in patients after cesarean section with a history of post-dural puncture headache. Intervention 2: Intervention group 2: Administration of 100 mg capsule of caffeine (Weider - Canada) orally every 12 hours for 3 days in patients after cesarean section with a history of post-dural puncture headache. Yes - There is a plan to make this available What will be shared: Part of data on the primary outcomes will be shared. When: Six months after the publication of the results data access is possible. To whom: ŮŽAcademic researchers Conditions: Meta-analysis is allowed. Where to obtain: Dr. Negin Ghadami via Email: ghadaminegin@gmail.com How to obtain: Three months after the request, the data will be sent. Comments:
public Negin Ghadami
Bessat Hospital Keshavarz street
Sanandaj Iran (Islamic Republic of) 6614713446 +98 87 3324 8519 ghadaminegin@gmail.com Sanandaj University of Medical Sciences scientific Negin Ghadami
Bessat Hospital Keshavarz street
Sanandaj Iran (Islamic Republic of) 6614713446 +98 87 3324 8519 ghadaminegin@gmail.com Sanandaj University of Medical Sciences Iran (Islamic Republic of) Being in level 1 and 2 of the ASA classification system Incidence of post dural puncture headache Elective cesarean section surgery 18 years 45 years Female History of co-existing diseases such as asthma, cardiovascular disease, diabetes. History of caffeine or gabapentin allergy Need for other painkillers (such as acetaminophen) during the study period Preeclampsia and eclampsia History of chronic headaches and migraines G44 Other headache syndromes Treatment - Drugs Treatment - Drugs Intervention group 1: Administration of 300 mg capsule of gabapentin(Mehr Darou- Tehran- Iran) orally every 12 hours for 3 days in patients after cesarean section with a history of post-dural puncture headache. Intervention group 2: Administration of 100 mg capsule of caffeine (Weider - Canada) orally every 12 hours for 3 days in patients after cesarean section with a history of post-dural puncture headache. Headache. Timepoint: At intervals of 24, 48 and 72 hours after starting treatment. Method of measurement: Visual Analogue Scale. Sanandaj University of Medical Sciences Approved 2020-11-10 Ethics committee of Kurdistan University of Medical Sciences Pasdaran St., Kurdistan University of Medical Sciences Sanandaj Kurdistan Iran (Islamic Republic of)