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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.

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.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20241028063524N2
Enrollment
176
Registered
2024-12-27
Start date
2025-02-01
Completion date
Unknown
Last updated
2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.. Delivery by elective caesarean section

Interventions

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 intravenou

Sponsors

University of Nigeria Teaching Hospital,Enugu,Nigeria
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Nigeria

Contacts

Public ContactDr . Ogwueleka, Chukwudubem Vitalis

University of Nigeria Teaching Hospital,Enugu,Nigeria

dubemogwueleka@gmail.com+234 806 902 4516

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026