Post-Dural Puncture HeadachePhase 4RCTNCT03997006
Is Aminophylline More Effective Than Neostigmine/Atropine Mixture in the Treatment of Post-dural Puncture Headache
A Phase 4 study testing IV Aminophylline and IV Neostigmine Methylsulfate + Atropine Sulphate in people with Post-Dural Puncture Headache, run by Damanhour Teaching Hospital at 1 site in Egypt.
Trial summary
Objectives: To compare the safety and efficacy of IV aminophylline versus IV neostigmine/atropine mixture in the treatment of post-dural puncture headache (PDPH). Background: PDPH is the most frequent complication of procedures associated with dural puncture for spinal anesthesia or following accidental dural puncture… Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Post-Dural Puncture Headache
- What is being tested?
- IV Aminophylline and IV Neostigmine Methylsulfate + Atropine Sulphate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 1 Jan 2020
- Phase
- Phase 4
- 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 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with NPRS score of ≥ 5
- American Society of Anesthesiologists (ASA) physical status ≤ II
- Age from 21 to 50 years
Who cannot join
- Patients with NPRS score < 5
- ASA physical status > II
- Age < 21 years or > 50 years
- Pregnant women
- History of; chronic headache, Cluster headache, Migraine
- History of; Convulsions, Cerebrovascular accident, Previous neurological diseases
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- Signs of meningismus
- Bronchial asthma
- Arrhythmia
- Hypertension
- Ischemic heart disease
- Hyperthyroidism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Aminophylline More Effective Than Neostigmine/Atropine Mixture in the Treatment of Post-dural Puncture Headache: A Randomized Clinical Trial
Objectives: To compare the safety and efficacy of IV aminophylline versus IV neostigmine/atropine mixture in the treatment of post-dural puncture headache (PDPH).
Background: PDPH is the most frequent complication of procedures associated with dural puncture for spinal anesthesia or following accidental dural puncture during epidural anesthesia. Since invasive treatments have known complications, pharmacologic management may be preferable.
Patients and Methods: This was a prospective, randomized, double-blind, phase four clinical trial; carried out on 60 patients presented with PDPH at our hospital. Patients were randomly allocated into two equal groups (30 patients each); group A, received IV aminophylline, and group NA, received IV neostigmine/atropine mixture.
- Conditions
- Post-Dural Puncture Headache
- Being tested
- IV Aminophylline, IV Neostigmine Methylsulfate + Atropine Sulphate
- Keywords
- Aminophylline, Atropine, Neostigmine, Post-dural puncture headache, Spinal anesthesia
- 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.
IV AminophyllineDrug
Also called Minophylline-N ampoule
IV Aminophylline (100 mg/8h)
IV Neostigmine Methylsulfate + Atropine SulphateDrug
Also called Neostigmine ampoule, Atropine ampoule
IV Neostigmine/Atropine mixture (20 μg/kg Neostigmine + 10 μg/kg Atropine)/8h
| Study group | Role | What they receive |
|---|---|---|
| Group A (n=30) | Active comparator | Aminophylline group Receives: Drug: IV Aminophylline |
| Group NA (n=30) | Active comparator | Neostigmine/Atropine group Receives: Drug: IV Neostigmine Methylsulfate + Atropine Sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median and Range of Numeric Pain Rating Scale (NPRS) score
NPRS measures the severity of PDPH, it is a 11 point scale from 0-10; where 0=No pain and 10=Worst possible pain (before, 2h, 6h, 12h, then every 12h till 48h)
Measured: 48 hours after initiation of treatment
Secondary outcomes (2)
Mean and Standard deviation of PDPH duration (hours) (mean±SD)
Time from PDPH onset till NPRS score ≤ 3
Measured: 48 hours after initiation of treatment
Number of participants and Rate of Treatment-related complications
Number of participants and Rate of: Diarrhea, Palpitation, Abdominal cramps, Muscle twitches, Bronchospasm, Urinary bladder hyperactivity
Measured: 48 hours after initiation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start1 Jan 2019
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damanhour Teaching Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ahmed M Shaat, MD, Principal investigator, Damanhour Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03997006
- Sponsor's protocol ID
- DTH:19001
- Acronym
- RCT
- Status last verified
- Feb 2020
- First submitted
- 20 Jun 2019
- Last updated
- 5 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Aminophylline More Effective Than Neostigmine/Atropine Mixture in the Treatment of Post-dural Puncture Headache: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03997006
- Acronym / sponsor ID
- RCT / DTH:19001
- Conditions
- Post-Dural Puncture Headache
- Keywords
- Aminophylline, Atropine, Neostigmine, Post-dural puncture headache, Spinal anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Damanhour Teaching HospitalOther government
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 25 Jun 2019 (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.
Objectives: To compare the safety and efficacy of IV aminophylline versus IV neostigmine/atropine mixture in the treatment of post-dural puncture headache (PDPH).
Background: PDPH is the most frequent complication of procedures associated with dural puncture for spinal anesthesia or following accidental dural puncture during epidural anesthesia. Since invasive treatments have known complications, pharmacologic management may be preferable.
Patients and Methods: This was a prospective, randomized, double-blind, phase four clinical trial; carried out on 60 patients presented with PDPH at our hospital. Patients were randomly allocated into two equal groups (30 patients each); group A, received IV aminophylline, and group NA, received IV neostigmine/atropine mixture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (n=30) | Active comparator | Drug: IV AminophyllineAminophylline group |
| Group NA (n=30) | Active comparator | Drug: IV Neostigmine Methylsulfate + Atropine SulphateNeostigmine/Atropine group |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with NPRS score of ≥ 5
- American Society of Anesthesiologists (ASA) physical status ≤ II
- Age from 21 to 50 years
Key exclusion criteria (12 listed)
- Patients with NPRS score < 5
- ASA physical status > II
- Age < 21 years or > 50 years
- Pregnant women
- History of; chronic headache, Cluster headache, Migraine
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 |
|---|---|---|
| IV AminophyllineAlso: Minophylline-N ampouleIV Aminophylline (100 mg/8h) | Drug | Group A (n=30) |
| IV Neostigmine Methylsulfate + Atropine SulphateAlso: Neostigmine ampoule, Atropine ampouleIV Neostigmine/Atropine mixture (20 μg/kg Neostigmine + 10 μg/kg Atropine)/8h | Drug | Group NA (n=30) |
Primary outcome
Median and Range of Numeric Pain Rating Scale (NPRS) score
Time frame: 48 hours after initiation of treatment
NPRS measures the severity of PDPH, it is a 11 point scale from 0-10; where 0=No pain and 10=Worst possible pain (before, 2h, 6h, 12h, then every 12h till 48h)
2 secondary outcomes
Mean and Standard deviation of PDPH duration (hours) (mean±SD)
Time frame: 48 hours after initiation of treatment
Number of participants and Rate of Treatment-related complications
Time frame: 48 hours after initiation of treatment
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 5 Feb 2020.
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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.
Ahmed M Shaat, MD principal investigator
Damanhour Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IV Aminophylline and IV Neostigmine Methylsulfate + Atropine Sulphate in people with Post-Dural Puncture Headache, run by Damanhour Teaching 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 12 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 5 Feb 2020. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Median and Range of Numeric Pain Rating Scale (NPRS) score (time frame: 48 hours after initiation of treatment). 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 5 Feb 2020.