Nebulized Dexmedetomidine Versus Oral Sumatriptan in Treatment of Post Dural Puncture Headache in Cesarean Section

Not Applicable

Completed

• Conditions: Post-Dural Puncture Headache
• Interventions: Drug: Sumatriptan 25 mg; Drug: Precedex

• Registration Number: NCT06514040
• Lead Sponsor: Fayoum University Hospital

Brief Summary

comparison between oral sumatriptan and Nebulized Dexmedetomidine in Post Dural Puncture Headache in Cesarean Section

Detailed Description

A total of 48 patients will be randomly chosen to receive either inhaled dexmedetomidine (Group D, n= 24) or oral sumatriptan (Group S, n= 24) by a random sequence number generated by the computer kept in sealed envelopes. Those envelopes will be opened once the patient is recruited and participants will receive either inhaled dexmedetomidine or oral sumatriptan as per the envelope. Data collectors will be blinded to the type of used medication (Dexmedetomidine or Sumatriptan).

Study Timeline

• Study Start: 2023-11-27
• Study First Submitted: 2024-05-09
• Study First Submitted QC: 2024-07-20
• Study First Posted: 2024-07-23
• Primary Completion: 2024-08-15
• Study Completion: 2024-09-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sumatriptan group	Sumatriptan 25 mg	2- Oral sumatriptan group (Group S, n= 24): sumatriptan 25 mg every 8 hours orally when occurrence of side effects in form of paresthesia, dizziness and chest tightness stop the medication.
Precedex group	Precedex	1- Inhaled Dexmedetomidine group (Group D, n= 24): will receive nebulization of 1 µg/kg dexmedetomidine (Precedex, Dexmedetomidine HCl 100 µg/mL, Pfizer Inc.) diluted in 4 mL 0.9% saline twice daily starting from the PDPH diagnosis time. The intervention will be continued until achieving a VAS score ≤ 3 and Lybecker classification score \< 2 or for a maximum of 48 hours when occurrence of side effects in form of hypotension, bradycardia, nausea stop the medication and give supportive treatment.

Primary Outcome Measures

Name	Time	Method
visual analogue scale	First 48 hours	VAS Score from 0 to 10 where score 0 is no headache and 10 is the worst one

Secondary Outcome Measures

Name	Time	Method
visual analogue scale	42 hours.	VAS Score from 0 to 10 where score 0 is no headache and 10 is the worst one
Lybecker score	36 hours	Mild; Mild:Daily activities slightly restricted. Patient is not bedridden; No associated symptoms; Moderate:Daily activities significantly restricted and most of the day patient is bedridden with or without associated symptoms; Severe:Daily activities completely restricted, patient is bedridden all the day and always with associated symptoms

Trial Locations

Locations (1)

Fayoum University hospital; 🇪🇬 Madīnat Al Fayyūm, Faiyum Governorate, Egypt