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A comparitive study between two medicines-dexmedetomidine and fentanyl for treating severe headaches in mothers after a caesarean section

A comparative study between the use of nebulized Dexmedetomidine and nebulized Fentanyl in parturients experiencing post-dural puncture headache (PDPH) following caesarean section under spinal anaesthesia - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/107679
Enrollment
80
Registered
2026-04-07
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Health Condition 1: 1- Obstetrics

Interventions

Intervention1: Nebulised Dexmedetomidine: 1 mcg/kg in 4 ml 0.9 % normal saline nebulization 12 hourly Control Intervention1: Nebulised Fentanyl: 1 mcg/kg in 4 ml 0.9 % normal saline nebulization 12 ho

Sponsors

KPC Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients belonging to ASA Grade II and III Patients giving informed written valid consent. Subjects that qualified the PDPH criteria as per International Headache Society with headache severity scores of greater than 4

Exclusion criteria

Exclusion criteria: Age less than 18 years and more than 35 years Known allergy to the anesthetic agents involved in the study Known case of cardiovascular disorders, specifically bradyarrhythmias. Patients with chronic treatment of headache of other causes, history of migraine, history of epilepsy, history of substance abuse and current opioid use. Patients who are uncooperative or disoriented. Parturients with Body mass index greater than 25 kg/m2 Known cases of gestational hypertension

Design outcomes

Primary

MeasureTime frame
Headache severity as measured using Numeric Pain Rating Scale (NPRS) after 24 hours of the first nebulisation using Dexmedetomidine versus FentanylTimepoint: At baseline,1,6,12,24,48 and 72 hours

Secondary

MeasureTime frame
To compare the duration of PDPH while using 12 hourly nebulization of dexmedetomidine versus fentanyl. Timepoint: At baseline,1,6,12,24,48 & 72 hours;To compare the hemodynamics after 24 hours of nebulization using dexmedetomidine versus fentanylTimepoint: At baseline,1,6,12,24,48 & 72 hours

Countries

India

Contacts

Public ContactSpandan Paul

KPC Medical College and Hospital

drsourabhroy@gmail.com9836275531

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026