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

Nebulized Dexmedetomidine Versus Oral Sumatriptan for Treatment of Post-Dural Puncture Headache Following Caesarian Section (Randomized Comparative Study)

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

Study Overview

• Status: Completed
• Conditions: Post-Dural Puncture Headache
• Intervention / Treatment: Drug: Precedex; Drug: Sumatriptan 25 mg

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Faiyum Governorate
    • Madīnat Al Fayyūm, Faiyum Governorate, Egypt
      • Fayoum University hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria:

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

Exclusion criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Precedex group; 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; Dexmedetomidine (Precedex) is a highly selective alpha 2 adrenoreceptor agonist which produce sedation, anxiolysis, analgesia, and decreasing inflammatory response to anaesthesia and surgical procedure.
Active Comparator: Sumatriptan group; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analogue scale	VAS Score from 0 to 10 where score 0 is no headache and 10 is the worst one	6 hours.
visual analogue scale	VAS Score from 0 to 10 where score 0 is no headache and 10 is the worst one	12 hours.
visual analogue scale	VAS Score from 0 to 10 where score 0 is no headache and 10 is the worst one	18 hours.
visual analogue scale	VAS Score from 0 to 10 where score 0 is no headache and 10 is the worst one	24 hours.
visual analogue scale	VAS Score from 0 to 10 where score 0 is no headache and 10 is the worst one	30 hours.
visual analogue scale	VAS Score from 0 to 10 where score 0 is no headache and 10 is the worst one	36 hours.
visual analogue scale	VAS Score from 0 to 10 where score 0 is no headache and 10 is the worst one	42 hours.
Lybecker score	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	6 hours
Lybecker score	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	12 hours
Lybecker score	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	18 hours
Lybecker score	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	24 hours
Lybecker score	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	30 hours
Lybecker score	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	36 hours

Collaborators and Investigators

• Sponsor: Fayoum University Hospital
• Investigators: Principal Investigator: Mohamed A Hamed, MD, Faculty of medicine,Fayoum University

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2023
• Primary Completion (Actual): August 15, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: May 9, 2024
• First Submitted That Met QC Criteria: July 20, 2024
• First Posted (Actual): July 23, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders; Headache Disorders, Secondary; Headache; Post-Dural Puncture Headache; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Neurotransmitter Agents; Hypnotics and Sedatives; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Serotonin Agents; Vasoconstrictor Agents; Serotonin Receptor Agonists; Serotonin 5-HT1 Receptor Agonists; Dexmedetomidine; Sumatriptan
• Other Study ID Numbers: M684

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No