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A Study Comparing Inhaled Dexmedetomidine with Inhaled Fentanyl for Treating Headache After Spinal Anaesthesia

Nebulised Dexmedetomidine Versus Nebulised Fentanyl for the Treatment of Post-Dural Puncture Headache (PDPH) Following Spinal Anaesthesia: A Randomised Controlled Trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/091853
Enrollment
80
Registered
2025-07-28
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Nebulised Dexmedetomidine: Patients in Group D will receive nebulised dexmedetomidine 1 mcg/kg (4ml) every 12 hours for the first 72 hours in a semi-recumbent position using a nebulise

Sponsors

DR KESHAVI BHARADWAJ
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients willing to participate 2. Patients of physical status I/II according to American Society of Anaesthesiologists Grading 3. Patients developing PDPH post lower abdominal and lower limb surgeries under spinal anaesthesia within 72 hours 4. Patients qualifying for the criteria of PDPH (with headache severity score more than 4) as laid down by the International Headache Society

Exclusion criteria

Exclusion criteria: 1. Patients having history of allergy to the study drug 2. Patients with body mass index less than 25kg/m2 3. Patient with history of migraine or other types of headache, on chronic treatment of headache 4. Patients with hemodynamic instability or bradyarrythmias

Design outcomes

Primary

MeasureTime frame
To compare the severity of headache after 24 hours of 1st nebulisationTimepoint: 24 hours post 1st nebulisation

Secondary

MeasureTime frame
To assess the incidence rate of PDPH at tertiary care centre, calculate the number of patients requiring additional analgesics, asses any adverse effects (hypotension, bradycardia, oxygen desaturation, dry mouth, sneezing and coughing) during and after nebulisation, compare the analgesic effect of nebulised dexmedetomidine to fentanyl using VAS scoreTimepoint: At 0, 12, 24, 36, 48 and 72 hours of nebulisation

Countries

India

Contacts

Public ContactDR BIBHA KUMARI

Indira Gandhi Institute of Medical Sciences

keshavibharadwaj@gmail.com9711878236

Outcome results

None listed

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