Comparison of Acetaminophen With Aminophylline and Aminophylline With Dexamethasone for Prophylaxis of PDPH in Patients With History of PDPH. (PDPH)

April 9, 2026 updated by: Sargodha Medical College

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • Pakistan
    • Punjab Province
      • Sargodha, Punjab Province, Pakistan, 40100
        • Dr.Faisal Masood Teaching Hospital, Sargodha

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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • History of known allergy or hypersensitivity against study drug
  • Emergency surgery
  • Obstetric patient
  • Failed spinal
  • Multiple attempts of spinal
  • Contraindication to Spinal Anesthesia
  • 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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acetaminophen+Aminophylline (n=25)
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.
Drug: Inj Aminophylline 100mg with Inj Acetaminophen 1000mg in 100ml Normal Saline
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.
Other Names:
  • Acetaminophen
  • Aminophylline
Experimental: Aminophylline+Dexamethasone (n=25)
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.
Drug: Inj Aminophylline 100mg , with 0.1mg/kg Dexamethasone in 100ml Normal Saline
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.
Other Names:
  • Dexamethasone
  • Aminophylline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
● 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.
3 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
*Reduced need for Rescue analgesia and *Reduced associated symptoms of PDPH after prophylactic administration of Aminophylline with Acetaminophen and Aminophylline with Dexamethasone.
Time Frame: 3 days

The combination of Aminophylline with Acetaminophen and Aminophylline with Dexamethasone reduce the need for rescue analgesia.

Moreover, the combination of drugs reduce the associated symptoms of PDPH like diplopia, nausea, vomiting and neck stiffness.
3 days

Collaborators and Investigators

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

Sponsor

Sargodha Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.

Helpful Links

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)

August 1, 2023

Primary Completion (Actual)

June 2, 2024

Study Completion (Actual)

July 8, 2024

Study Registration Dates

First Submitted

February 24, 2026

First Submitted That Met QC Criteria

April 9, 2026

First Posted (Actual)

April 14, 2026

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMC-ANS-2025-005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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