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Completed

NCT Number: NCT06514040

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

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

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Key information

Conditions

Post-Dural Puncture Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Secondary Nervous System Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fayoum University hospital

El Fayoum Qesm, Faiyum Governorate, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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

Primary outcomes

  1. visual analogue scale

    Time frame: First 48 hours

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

Secondary outcomes

  1. visual analogue scale

    Time frame: 6 hours.

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

  2. visual analogue scale

    Time frame: 12 hours.

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

  3. visual analogue scale

    Time frame: 18 hours.

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

  4. visual analogue scale

    Time frame: 24 hours.

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

  5. visual analogue scale

    Time frame: 30 hours.

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

  6. visual analogue scale

    Time frame: 36 hours.

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

  7. visual analogue scale

    Time frame: 42 hours.

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

  8. Lybecker score

    Time frame: 6 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

  9. Lybecker score

    Time frame: 12 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

  10. Lybecker score

    Time frame: 18 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

  11. Lybecker score

    Time frame: 24 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

  12. Lybecker score

    Time frame: 30 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

  13. Lybecker score

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Fayoum University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 23, 2024
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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