NCT07528118

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

Comparison of Prophylactic Intravenous Acetaminophen With Aminophylline and Aminophylline With Dexamethasone for Post Dural Puncture Headache Prevention in Surgical Patients With History of PDPH

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Sargodha Medical College · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2023-08-01
• Primary completion: 2024-06-02
• Completion: 2024-07-08
• First posted: 2026-04-14
• Last updated: 2026-04-14

Locations

1 site across 1 country: Pakistan