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IRCT20230920059483N1 IRCT 2024-02-10 Combined Military Hospital Kharian, Pakistan Addition of neostigmine and atropine to standard post-dural puncture headache Comparison between neostigmine and atropine added to standard post-dural puncture headache regimen versus standard regimen alone 2023-01-01 anticipated 130 Complete https://irct.ir/trial/72737 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Double blind interventional randomized controlled trial. This randomized controlled trial was carried out at Anesthesia department of Combined Military Hospital, Kharian The patients were divided into the modified treatment group (Group M) (n=65) and the standard treatment group (Group S) (n=65) after randomization. One was given the standard regimen and the other received the modified regimen with atropine added. The method of randomization was simple non-probability consecutive sampling via lottery method. The lottery envelopes were placed in the pre-anesthesia clinic and patients presenting for treatment of PDPH were asked to pick one at random and segregated into one of the two groups. The randomization was done in sealed envelopes with the resident consultant on duty containing pre-prepared treatment vials as unmarked syringes to be given in both groups according to the treatment guide, Blinding description: This was a double-blind study and once the patients were divided into the two groups, both the drug administering anesthetist and the anesthetist recording the results were unaware of the study protocol or the randomization group details. The lottery envelopes were placed in the pre-anesthesia clinic and patients presenting for treatment of PDPH were asked to pick one at random and segregated into one of the two groups. The randomization was done in sealed envelopes with the resident consultant on duty containing pre-prepared treatment vials as unmarked syringes to be given in both groups according to the treatment guide. Both the patient as well as the resident giving the treatment was unaware of the drugs being given as well as the study protocol. Proforma for analysis was also marked with nondescript group to blind the assessor of the outcome of each group of study. 2 Post dural puncture headache. Intervention 1: Intervention group: Group M (Modified regimen group) Patients in the modified regimen received the same protocol and drugs of the standard regimen as well as IV neostigmine 20 mcg/kg and atropine 10 mcg/kg in 20 ml in the same 8 hourly intervals till the time pain threshold on the visual analog scale was <3. Patients with VAS <3 before 72 hours were still given 20 ml of 0.9% normal saline to maintain blinding. Intervention 2: Intervention group: Group S (Standard regimen group) Patients in the standard regimen received the institute followed conservative management of IV Paracetamol 15mg/kg, IV Ibuprofen 5 mg/kg, IV Ondansetron 4 mg, IV Omeprazole 40 mg, Ringer lactate at 1.5 ml/kg/hr and caffeine 135 mg. Yes - There is a plan to make this available What will be shared: The data will be shared after the manuscript approval by the concerned publishing journal. Request to be forwarded to the main focal person given in details by email and after permission would be shared by email to the requesting person/organization. When: After approval of manuscript for publication and would be available with the focal person and organization indefinitely To whom: For research and academic institutions after permission from the focal person. Conditions: For research and academic purposes only Focal person given in details and email address provided to be used for all queries Where to obtain: From the focal person via email after formal request and approval from the institute. Process would be done by the focal person. How to obtain: A formal email requesting the data required with official name and designation of the person requiring. Would be given after focal person receives confirmation from own institute to share the data. Approximate processing time 7-10 days. Comments:
public Dr Qaim Ali Bhatti
CMH hospital , kharian cantt
Kharian Pakistan 50090 +92 331 6333113 qaimalibhatty@gmail.com Combined Military Hospital Kharian scientific Dr Qaim Ali Bhatti
CMH hospital , kharian cantt
Kharian Pakistan 50090 +92 331 6333113 qaimalibhatty@gmail.com Combined military hospital kharian Pakistan Included all patients with post-dural puncture headache diagnosed according to the International Headache Society Criteria, presenting to the anesthesia clinic 48-72 hours after caesarian delivery. 25 years 35 years Female Patients unwilling for IV or oral therapy Refusal to be included in the study Patients with allergy to either atropine, neostigmine, paracetamol and/or ibuprofen Patients with known history of migraine, cluster headache, patients on anti-depressants Patients with any neurological disease and patients with major respiratory and cardiac disease. G44 Other headache syndromes Treatment - Drugs Treatment - Drugs Intervention group: Group M (Modified regimen group) Patients in the modified regimen received the same protocol and drugs of the standard regimen as well as IV neostigmine 20 mcg/kg and atropine 10 mcg/kg in 20 ml in the same 8 hourly intervals till the time pain threshold on the visual analog scale was <3. Patients with VAS <3 before 72 hours were still given 20 ml of 0.9% normal saline to maintain blinding. Intervention group: Group S (Standard regimen group) Patients in the standard regimen received the institute followed conservative management of IV Paracetamol 15mg/kg, IV Ibuprofen 5 mg/kg, IV Ondansetron 4 mg, IV Omeprazole 40 mg, Ringer lactate at 1.5 ml/kg/hr and caffeine 135 mg. Pain on Visual Analog Scale. Timepoint: 6,12,24,48,72 hours after intervention. Method of measurement: Standard Visual Analog Scale. Nausea. Timepoint: Within 72 hours after intervention. Method of measurement: Patient history and observation in the wards. Neck stiffness. Timepoint: Within 72 hours after intervention. Method of measurement: Physical examination. Need for blood patch. Timepoint: Within 72 hours of intervention. Method of measurement: Non-responsive to standard IV treatment after 24 hours. Combined Military Hospital Kharian, Pakistan Approved 2022-12-25 Ethical review board CMH Kharian, Pakistan Main GT Road Kharian Punjab Pakistan