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IRCT20241028063524N2 IRCT 2024-12-27 University of Nigeria Teaching Hospital,Enugu,Nigeria Comparison of the effects of intravenous ondansetron, paracetamol and both drugs in prevention of post-dural puncture headache following spinal anaesthesia for caesarean section;A double-blind randomised controlled trial. PDPHT Comparison of the effects of intravenous ondansetron, paracetamol and both drugs in prevention of post-dural puncture headache following spinal anaesthesia for caesarean section;A double-blind randomised controlled trial. 2025-02-01 anticipated 176 Complete https://irct.ir/trial/80639 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Already described in the randomization section, Randomization description: The randomization of 176 pregnant women will be accomplished utilizing a computer-generated randomization schedule (Stat-Trek Generator), and placed into consecutively numbered, opaque, sealed envelopes. The eligible women will be assigned by means of these computer-generated random numbers into 4 sample groups; intervention group A ( will receive Ondansetron alone), intervention group B(will receive Paracetamol alone), intervention group C( will receive combination of ondansetron and paracetamol) and control group D(will receive water for injection) .Thus, once the patient is deemed eligible and has given informed consent, she will be assigned a sequential study number. Block randomization of all eligible consenting patients will be done using computer generated random sequence and a randomization ratio of 1:1:1: 1. Upon enrolment, an opaque envelope containing the patient enrolment number and assignment to any of the groups,will be opened and the unique number placed on the patient’s antenatal card. Each participant will be assigned a unique subject number for identity and confidentiality, Blinding description: The participants and the outcome assessors will not know which injection will be given to any of the participants. 3 Post-dural puncture headache is a headache that develops within 5 days after dural puncture which worsens in an upright position and improves with lying down and accompanied by neck stiffness, tinnitus, photophobia, and nausea.. Intervention 1: Intervention group A:This group will receive 8mg and 600mg of intravenous ondansetron and paracetamol respectively. Intervention 2: Intervention group B will receive 8mg of intravenous ondansetron. Intervention 3: Intervention group C will receive 600mg of intravenous paracetamol. Intervention 4: Control group D will receive water for injection (placebo). Yes - There is a plan to make this available What will be shared: The data will be provided only on request. When: It will be provided after publication of the project and last for 2 years To whom: It will be provided to the publishing journal Conditions: For secondary analysis of the data and for understudy of the data by another researcher. Where to obtain: The journal that will publish the research work or by contacting Prof. Leonard O. Ajah through leonard.ajah@unn.edu.ng How to obtain: It requires writing the corresponding author and stating the aim of the request of the data Comments: Already stated above
public Dr . Ogwueleka, Chukwudubem Vitalis
Ituku-Ozalla
Enugu Nigeria 40001 +234 806 902 4516 dubemogwueleka@gmail.com University of Nigeria Teaching Hospital,Enugu,Nigeria scientific Leonard Ajah
University of Nigeria
Enugu Nigeria 400001 +234 803 392 0789 leonard.ajah@unn.edu.ng University of Nigeria Teaching Hospital,Enugu,Nigeria Nigeria Nigeria Nigeria 1. Booked patient at term attending antenatal care at the study centers. 18 – 40-year-old. ASA I and II parturients undergoing elective caesarean section under spinal anaesthesia. 18 years 40 years Female Patients with known contraindication to spinal anaesthesia Allergy to the study drugs Patients with comorbidities like pregnancy induced hypertension, gestational diabetes mellitus, coronary artery disease or heart disease Patients taking drugs like selective serotonin receptor inhibitors (SSRIs) Patients converted into general anaesthesia 082.0 Delivery by elective caesarean section Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo Intervention group A:This group will receive 8mg and 600mg of intravenous ondansetron and paracetamol respectively. Intervention group B will receive 8mg of intravenous ondansetron Intervention group C will receive 600mg of intravenous paracetamol Control group D will receive water for injection (placebo). The primary outcome measure will be the incidence of post dural puncture headache within 24 hours following caesarean delivery. Timepoint: At 6,12,18 and 24 hours post-caesarean section. Method of measurement: This will be assessed using the visual analogue scale. Maternal complications (spinal anaesthesia induced hypotension, intra operative and post operative nausea and vomiting). Timepoint: 1 hour,6 hours,12 hours,18 hours,24 hours. Method of measurement: Blood pressure check and report of any incidence of nausea and vomiting. Neonatal complications (Apgar scores at 1 and 5 min, the need for cardiopulmonary resuscitation and admission to the neonatal intensive care unit (NICU) during the first 24 hours after delivery will be assessed too). Timepoint: 1 minute,5 minutes, 24 hours. Method of measurement: APgar scoring and report of any incidence of the above interventions. University of Nigeria Teaching Hospital,Enugu,Nigeria Approved 2024-11-27 University of Nigeria Teaching Hospital Research and Ethics Committee Ituku-Ozalla Enugu Enugu Nigeria