Post Dural Puncture HeadachePhase 2PDPHNCT07528118
Comparison of Acetaminophen With Aminophylline and Aminophylline With Dexamethasone for Prophylaxis of PDPH in Patients With History of PDPH.
A Phase 2 study testing Inj Aminophylline 100mg with Inj Acetaminophen 1000mg in 100ml Normal Saline and Inj Aminophylline 100mg , with 0.1mg/kg Dexamethasone in 100ml Normal Saline in people with Post Dural Puncture Headache, run by Sargodha Medical College at 1 site in Pakistan.
Trial summary
It is hypothesized that there is a difference between intravenously administered aminophylline with intravenous acetaminophen and intravenously administered aminophylline with dexamethasone for prevention of and reducing severity of PDPH. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Post Dural Puncture Headache
- What is being tested?
- Inj Aminophylline 100mg with Inj Acetaminophen 1000mg in 100ml Normal Saline and Inj Aminophylline 100mg , with 0.1mg/kg Dexamethasone in 100ml Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2023to 8 Jul 2024
- Phase
- Phase 2
- 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
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients from 18-40 years.
- Elective surgery under spinal anesthesia
- Those patients having history of PDPH
- BMI≤ 35kg/m2
- American Society of Anesthesiologist (ASA) Physical Status I and II
Who cannot join
- History of known allergy or hypersensitivity against study drug
- Emergency surgery
- Obstetric patient
- Failed spinal
- Multiple attempts of spinal
- Contraindication to Spinal Anesthesia
Show all 12Show fewer
- Chronic disease patients already taking opioids or NSAIDs
- History of migraine or other headaches
- Partially effective spinal anesthesia
- Abnormal liver or kidney function, cardiovascular system diseases, respiratory system diseases and diseases of the nervous system
- Intraoperative blood loss >1000ml
- Intraoperative hemodynamic instability
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Dr.Faisal Masood Teaching Hospital, Sargodha
Sargodha, Punjab Province, 40100
About this study
Official title: Comparison of Prophylactic Intravenous Acetaminophen With Aminophylline and Aminophylline With Dexamethasone for Post Dural Puncture Headache Prevention in Surgical Patients With History of PDPH
It is hypothesized that there is a difference between intravenously administered aminophylline with intravenous acetaminophen and intravenously administered aminophylline with dexamethasone for prevention of and reducing severity of PDPH.
Read the detailed description
Aim of the study is to compare intravenous aminophylline plus dexamethasone with intravenous acetaminophen and intravenous aminophylline on post dural puncture headache prevention after spinal anesthesia in terms of incidence of PDPH, VAS scores between the groups. . Patients will be randomly divided into two equal groups. (Group A1) who will receive aminophylline with acetaminophen infusion slowly and (Group A2) who will receive aminophylline with dexamethasone Infusion. Study variables will be noted in predesigned study proforma. Data will be entered on software SPSS version 26.0 and will be analyzed.
- Conditions
- Post Dural Puncture Headache
- Being tested
- Inj Aminophylline 100mg with Inj Acetaminophen 1000mg in 100ml Normal Saline, Inj Aminophylline 100mg , with 0.1mg/kg Dexamethasone in 100ml Normal Saline
- Keywords
- PDPH, Acetaminophen, Aminophylline, Dexamethasone
- 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.
Inj Aminophylline 100mg with Inj Acetaminophen 1000mg in 100ml Normal SalineDrug
Also called Aminophylline, Acetaminophen
This group will receive Inj. Aminophylline 100mg as slow IV. Infusion over 30 minutes followed by inj. Acetaminophen 1000mg in 100 ml Normal saline solution as slow infusion.
Inj Aminophylline 100mg , with 0.1mg/kg Dexamethasone in 100ml Normal SalineDrug
Also called Aminophylline, Dexamethasone
This group will receive Inj. Aminophylline 100mg as slow IV infusion over 30minutes followed by 0.1mg/kg dexamethasone in 100ml Normal saline IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| Acetaminophen+Aminophylline (n=25) | Experimental | This group will receive Inj. Aminophylline 100mg as slow IV. Infusion over 30 minutes followed by inj. Acetaminophen 1000mg in 100 ml Normal saline solution as slow infusion. Receives: Drug: Inj Aminophylline 100mg with Inj Acetaminophen 1000mg in 100ml Normal Saline |
| Aminophylline+Dexamethasone (n=25) | Experimental | This group will receive Inj. Aminophylline 100mg as slow IV infusion over 30minutes followed by 0.1mg/kg dexamethasone in 100ml Normal saline IV infusion. Receives: Drug: Inj Aminophylline 100mg , with 0.1mg/kg Dexamethasone in 100ml Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome of the study is to see effectiveness of intravenous aminophylline in combination with dexamethasone and acetaminophen in terms of reducing incidence of PDPH in surgical patients with history of PDPH.
Reduced Incidence of PDPH
Measured: 3 days
Secondary outcomes (1)
Prophylactic administration of Aminophylline with Acetaminophen and Aminophylline with Dexamethasone on post-dural puncture headache prevention after spinal anesthesia in terms of reduced severity of PDPH by VAS scores.
● Reduced serverity of PDPH by VAS scores by prophylactic administration of Aminophylline with Acetaminophen and Aminophylline with Dexamethasone in patients with previous history of PDPH.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start1 Aug 2023
- Primary completion2 Jun 2024
- Study completion8 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After approval of synopsis and approval from Institutional Ethical Review Board (IERB), 50 patients undergoing elective lower abdominopelvic and lower limb surgeries as per inclusion criteria in this study will be enrolled in this study.Two equal groups will be constituted. Informed consent will be taken from all patients after explaining the whole procedure, its merits, demerits, and alternate treatment options. Group A1 (n=25) will receive Inj. Aminophylline 100mg as slow IV. Infusion over 30 minutes followed by inj. Acetaminophen 1000mg in 100 ml Normal saline solution as slow infusion. Group A2 (n=25) will receive Inj. Aminophylline 100mg as slow IV infusion over 30minutes followed by 0.1mg/kg dexamethasone in 100ml Normal saline IV infusion.Drugs will be given in infusion form at the end of the procedure and once daily for 3 days. Coded Drug infusions will be administered by an anesthetist blinded to study groups at the end of the procedure in operation theatre and once daily
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sargodha Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07528118
- Sponsor's protocol ID
- SMC-ANS-2025-005
- Acronym
- PDPH
- Status last verified
- Apr 2026
- First submitted
- 24 Feb 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jabalameli, M., Hashemi, S.T., Asadpoor, S., 2019. The efficacy of prophylactic intravenous aminophylline, paracetamol or aminophylline and paracetamol in prevention of post spinal headache in lower extremity surgeries compared to the control group. Tehran Univ. Medical J., 77(5), pp.294-300.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Prophylactic Intravenous Acetaminophen With Aminophylline and Aminophylline With Dexamethasone for Post Dural Puncture Headache Prevention in Surgical Patients With History of PDPH
- ClinicalTrials.gov ID
- NCT07528118
- Acronym / sponsor ID
- PDPH / SMC-ANS-2025-005
- Conditions
- Post Dural Puncture Headache
- Keywords
- PDPH, Acetaminophen, Aminophylline, Dexamethasone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sargodha Medical CollegeUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 2 Jun 2024 (actual)
- Study completion
- 8 Jul 2024 (actual)
- First posted
- 14 Apr 2026 (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.
It is hypothesized that there is a difference between intravenously administered aminophylline with intravenous acetaminophen and intravenously administered aminophylline with dexamethasone for prevention of and reducing severity of PDPH.
Detailed description
Aim of the study is to compare intravenous aminophylline plus dexamethasone with intravenous acetaminophen and intravenous aminophylline on post dural puncture headache prevention after spinal anesthesia in terms of incidence of PDPH, VAS scores between the groups. . Patients will be randomly divided into two equal groups. (Group A1) who will receive aminophylline with acetaminophen infusion slowly and (Group A2) who will receive aminophylline with dexamethasone Infusion. Study variables will be noted in predesigned study proforma. Data will be entered on software SPSS version 26.0 and will be analyzed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- After approval of synopsis and approval from Institutional Ethical Review Board (IERB), 50 patients undergoing elective lower abdominopelvic and lower limb surgeries as per inclusion criteria in this study will be enrolled in this study.Two equal groups will be constituted. Informed consent will be taken from all patients after explaining the whole procedure, its merits, demerits, and alternate treatment options. Group A1 (n=25) will receive Inj. Aminophylline 100mg as slow IV. Infusion over 30 minutes followed by inj. Acetaminophen 1000mg in 100 ml Normal saline solution as slow infusion. Group A2 (n=25) will receive Inj. Aminophylline 100mg as slow IV infusion over 30minutes followed by 0.1mg/kg dexamethasone in 100ml Normal saline IV infusion.Drugs will be given in infusion form at the end of the procedure and once daily for 3 days. Coded Drug infusions will be administered by an anesthetist blinded to study groups at the end of the procedure in operation theatre and once daily
| Arm | Type | Receives |
|---|---|---|
| Acetaminophen+Aminophylline (n=25) | Experimental | Drug: Inj Aminophylline 100mg with Inj Acetaminophen 1000mg in 100ml Normal SalineThis group will receive Inj. Aminophylline 100mg as slow IV. Infusion over 30 minutes followed by inj. Acetaminophen 1000mg in 100 ml Normal saline solution as slow infusion. |
| Aminophylline+Dexamethasone (n=25) | Experimental | Drug: Inj Aminophylline 100mg , with 0.1mg/kg Dexamethasone in 100ml Normal SalineThis group will receive Inj. Aminophylline 100mg as slow IV infusion over 30minutes followed by 0.1mg/kg dexamethasone in 100ml Normal saline IV infusion. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients from 18-40 years.
- Elective surgery under spinal anesthesia
- Those patients having history of PDPH
- BMI≤ 35kg/m2
- American Society of Anesthesiologist (ASA) Physical Status I and II
Key exclusion criteria (12 listed)
- History of known allergy or hypersensitivity against study drug
- Emergency surgery
- Obstetric patient
- Failed spinal
- Multiple attempts of spinal
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 |
|---|---|---|
| Inj Aminophylline 100mg with Inj Acetaminophen 1000mg in 100ml Normal SalineAlso: Aminophylline, AcetaminophenThis group will receive Inj. Aminophylline 100mg as slow IV. Infusion over 30 minutes followed by inj. Acetaminophen 1000mg in 100 ml Normal saline solution as slow infusion. | Drug | Acetaminophen+Aminophylline (n=25) |
| Inj Aminophylline 100mg , with 0.1mg/kg Dexamethasone in 100ml Normal SalineAlso: Aminophylline, DexamethasoneThis group will receive Inj. Aminophylline 100mg as slow IV infusion over 30minutes followed by 0.1mg/kg dexamethasone in 100ml Normal saline IV infusion. | Drug | Aminophylline+Dexamethasone (n=25) |
Primary outcome
The primary outcome of the study is to see effectiveness of intravenous aminophylline in combination with dexamethasone and acetaminophen in terms of reducing incidence of PDPH in surgical patients with history of PDPH.
Time frame: 3 days
Reduced Incidence of PDPH
1 secondary outcome
Prophylactic administration of Aminophylline with Acetaminophen and Aminophylline with Dexamethasone on post-dural puncture headache prevention after spinal anesthesia in terms of reduced severity of PDPH by VAS scores.
Time frame: 3 days
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 14 Apr 2026.
- BackgroundJabalameli, M., Hashemi, S.T., Asadpoor, S., 2019. The efficacy of prophylactic intravenous aminophylline, paracetamol or aminophylline and paracetamol in prevention of post spinal headache in lower extremity surgeries compared to the control group. Tehran Univ. Medical J., 77(5), pp.294-300.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Inj Aminophylline 100mg with Inj Acetaminophen 1000mg in 100ml Normal Saline and Inj Aminophylline 100mg , with 0.1mg/kg Dexamethasone in 100ml Normal Saline in people with Post Dural Puncture Headache, run by Sargodha Medical College at 1 site in Pakistan.
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 5 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 14 Apr 2026. 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 Pakistan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The primary outcome of the study is to see effectiveness of intravenous aminophylline in combination with dexamethasone and acetaminophen in terms of reducing incidence of PDPH in surgical patients with history of PDPH. (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07528118, which also lists 1 linked publication.
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 14 Apr 2026.