Comparison of Prophylactic Intravenous Acetaminophen With Aminophylline and Aminophylline With Dexamethasone for Post Dural Puncture Headache Prevention in Surgical Patients With History of PDPH
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Inj Aminophylline 100mg with Inj Acetaminophen 1000mg in 100ml Normal Saline (Drug)
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.
Intervention: Inj Aminophylline 100mg , with 0.1mg/kg Dexamethasone in 100ml Normal Saline (Drug)
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.
Time Frame: 3 days
Reduced Incidence of PDPH
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.(3 days)