CompletedPhase 2

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

Pakistan50 participantsStarted 2023-08-01

Plain-language 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.

Who can participate

Age range18 Years – 40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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.

Timeframe: 3 days

Trial details

NCT IDNCT07528118

SponsorSargodha Medical College

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-02

View on ClinicalTrials.gov More Post Dural Puncture Headache trials