Post-Dural Puncture HeadacheNCT06514040
Nebulized Dexmedetomidine Versus Oral Sumatriptan in Treatment of Post Dural Puncture Headache in Cesarean Section
A study testing Precedex and Sumatriptan 25 mg in people with Post-Dural Puncture Headache, run by Fayoum University Hospital at 1 site in Egypt.
Trial summary
comparison between oral sumatriptan and Nebulized Dexmedetomidine in Post Dural Puncture Headache in Cesarean Section Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post-Dural Puncture Headache
- What is being tested?
- Precedex and Sumatriptan 25 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Nov 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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).
- Conditions
- Post-Dural Puncture Headache
- Being tested
- Precedex, Sumatriptan 25 mg
- Medical subject headings
- Post-Dural Puncture Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrecedexDrug
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 mgDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Sumatriptan 25 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale
VAS Score from 0 to 10 where score 0 is no headache and 10 is the worst one
Measured: First 48 hours
Secondary outcomes (13)
visual analogue scale
VAS Score from 0 to 10 where score 0 is no headache and 10 is the worst one
Measured: 6 hours.
visual analogue scale
VAS Score from 0 to 10 where score 0 is no headache and 10 is the worst one
Measured: 12 hours.
visual analogue scale
VAS Score from 0 to 10 where score 0 is no headache and 10 is the worst one
Measured: 18 hours.
visual analogue scale
VAS Score from 0 to 10 where score 0 is no headache and 10 is the worst one
Measured: 24 hours.
visual analogue scale
VAS Score from 0 to 10 where score 0 is no headache and 10 is the worst one
Measured: 30 hours.
visual analogue scale
VAS Score from 0 to 10 where score 0 is no headache and 10 is the worst one
Measured: 36 hours.
visual analogue scale
VAS Score from 0 to 10 where score 0 is no headache and 10 is the worst one
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start27 Nov 2023
- Primary completion15 Aug 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Dural Puncture HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Hamed, Fayoum University Hospital
- Investigators
- Mohamed A Hamed, MD, Principal investigator, Faculty of medicine,Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514040
- Sponsor's protocol ID
- M684
- Status last verified
- Mar 2025
- First submitted
- 9 May 2024
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nebulized Dexmedetomidine Versus Oral Sumatriptan for Treatment of Post-Dural Puncture Headache Following Caesarian Section (Randomized Comparative Study)
- ClinicalTrials.gov ID
- NCT06514040
- Acronym / sponsor ID
- M684
- Conditions
- Post-Dural Puncture Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Fayoum University HospitalUniversity, hospital or other
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Precedex group | Active comparator | Drug: Precedex1- 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. |
| Sumatriptan group | Active comparator | Drug: Sumatriptan 25 mg2- 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrecedexDexmedetomidine (Precedex) is a highly selective alpha 2 adrenoreceptor agonist which produce sedation, anxiolysis, analgesia, and decreasing inflammatory response to anaesthesia and surgical procedure. | Drug | Precedex group |
| Sumatriptan 25 mgSumatriptan (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 | Drug | Sumatriptan group |
Primary outcome
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
13 secondary outcomes
visual analogue scale
Time frame: 6 hours.
visual analogue scale
Time frame: 12 hours.
visual analogue scale
Time frame: 18 hours.
visual analogue scale
Time frame: 24 hours.
visual analogue scale
Time frame: 30 hours.
visual analogue scale
Time frame: 36 hours.
visual analogue scale
Time frame: 42 hours.
Lybecker score
Time frame: 6 hours
Lybecker score
Time frame: 12 hours
Lybecker score
Time frame: 18 hours
Lybecker score
Time frame: 24 hours
Lybecker score
Time frame: 30 hours
Lybecker score
Time frame: 36 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Oral Gabapentin Versus Intravenous Neostigmine/Atropine Versus Combination of Both for Prevention of PDPH
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Dural Puncture Epidural With 27G vs 26G Needles Versus Standard Epidural for Elective Cesarean Delivery
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed A Hamed, MD principal investigator
Faculty of medicine,Fayoum University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Precedex and Sumatriptan 25 mg in people with Post-Dural Puncture Headache, run by Fayoum University Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analogue scale (time frame: First 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.