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

Sargodha Medical College50 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Post Dural Puncture Headache

Interventions

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

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

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

Dr.Faisal Masood Teaching Hospital, Sargodha

Sargodha, Punjab Province, Pakistan

Outcomes

Primary Outcomes

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

Time frame: 3 days

Secondary Outcomes

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.

Time frame: 3 days

Data from ClinicalTrials.gov

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