Skip to main content
OpenTrials
Completed

NCT Number: NCT07528118

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Post Dural Puncture Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Secondary Nervous System Diseases Post-Dural Puncture Headache

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dr.Faisal Masood Teaching Hospital, Sargodha

Sargodha, Punjab Province, 40100, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inj Aminophylline 100mg with Inj Acetaminophen 1000mg in 100ml Normal Saline

Drug

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: Aminophylline, Acetaminophen

Inj Aminophylline 100mg , with 0.1mg/kg Dexamethasone in 100ml Normal Saline

Drug

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: Aminophylline, Dexamethasone

Primary outcomes

  1. 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

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.

    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.

Other outcomes

  1. *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.

Sponsors and collaborators

Lead sponsor

Sargodha Medical College

Other

Registry information

Official study 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

Acronym: PDPH

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 14, 2026
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.