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

NCT06514040 | Completed DMC

• 1 other identifier: M684
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post-Dural Puncture Headache

Outcome Measures

Primary Outcomes (1)

• visual analogue scale

  VAS Score from 0 to 10 where score 0 is no headache and 10 is the worst one

  First 48 hours

Secondary Outcomes (13)

• visual analogue scale

  6 hours.

• visual analogue scale

  12 hours.

• visual analogue scale

  18 hours.

• visual analogue scale

  24 hours.

• visual analogue scale

  30 hours.

Study Arms (2)

Precedex group

ACTIVE COMPARATOR

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.

Drug: Precedex

Sumatriptan group

ACTIVE COMPARATOR

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.

Drug: Sumatriptan 25 mg

Interventions

Precedex DRUG

Dexmedetomidine (Precedex) is a highly selective alpha 2 adrenoreceptor agonist which produce sedation, anxiolysis, analgesia, and decreasing inflammatory response to anaesthesia and surgical procedure.

Precedex group

Sumatriptan 25 mg DRUG

Sumatriptan (Imigran) is a selective serotonin receptor agonist. It works by narrowing blood vessels in the brain, stopping pain signals from being sent to the brain, and blocking the release of certain natural substances that cause pain (as substance -p), nausea, and other symptoms of migraine

Sumatriptan group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Pregnant female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant female aged between 18 and 40 years old.
• ASA II and III undergoing elective caesarean section.
• Diagnosed with Postdural puncture headache with visual analogue score (VAS) ≥ 4 and Lybecker classification score ≥ 2.

You may not qualify if:

• Patient refusal.
• History of primary headaches such as migraine, cluster and tension headaches.
• Hypersensitivity of dexmedetomidine or sumatriptan.
• Hypertensive disorders of the pregnancy.
• Contraindication to spinal anesthesia as coagulopathy or infection at site of injection.
• Symptoms of ischemic heart disease (IHD) e.g. angina.
• Cerebrovascular disease e.g. stroke or transient ischemic attacks (TIAs).
• Using of Monoamine oxidase inhibitors (MAOIs) in the last 24h.

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

Fayoum University hospital

El Fayoum Qesm, Faiyum Governorate, Egypt

Location

MeSH Terms

Conditions

Post-Dural Puncture Headache

Interventions

Dexmedetomidine; Sumatriptan

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Mohamed A Hamed, MD

  Faculty of medicine,Fayoum University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: July 23, 2024
• Study Start: November 27, 2023
• Primary Completion: August 15, 2024
• Study Completion: September 30, 2024
• Last Updated: March 12, 2025

Record last verified: 2025-03

Locations

EG (1)