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

March 10, 2025 updated by: Mohamed Ahmed Hamed, Fayoum University Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
First 48 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
6 hours.
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
12 hours.
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
18 hours.
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
24 hours.
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
30 hours.
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
36 hours.
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
42 hours.
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
6 hours
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
12 hours
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
18 hours
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
24 hours
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
30 hours
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
36 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fayoum University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mohamed A Hamed, MD, Faculty of medicine,Fayoum University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 27, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 23, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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