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

NCT07528118 | Completed Phase 2

• 1 other identifier: SMC-ANS-2025-005
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Dural Puncture Headache

Keywords

PDPH; Acetaminophen; Aminophylline; Dexamethasone

Outcome Measures

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.

  Reduced Incidence of PDPH

  3 days

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.

  3 days

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.

  3 days

Study Arms (2)

Acetaminophen+Aminophylline (n=25)

EXPERIMENTAL

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 Inj Acetaminophen 1000mg in 100ml Normal Saline

Aminophylline+Dexamethasone (n=25)

EXPERIMENTAL

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.

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

Interventions

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.

Also known as: Aminophylline, Acetaminophen

Acetaminophen+Aminophylline (n=25)

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.

Also known as: Aminophylline, Dexamethasone

Aminophylline+Dexamethasone (n=25)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sargodha Medical College: lead

Study Sites (1)

Dr.Faisal Masood Teaching Hospital, Sargodha

Sargodha, Punjab Province, 40100, Pakistan

Location

Related Publications (1)

• Jabalameli, M., Hashemi, S.T., Asadpoor, S., 2019. The efficacy of prophylactic intravenous aminophylline, paracetamol or aminophylline and paracetamol in prevention of post spinal headache in lower extremity surgeries compared to the control group. Tehran Univ. Medical J., 77(5), pp.294-300.

  BACKGROUND

Related Links

• related info

MeSH Terms

Conditions

Post-Dural Puncture Headache

Interventions

Saline Solution; Aminophylline; Acetaminophen; Dexamethasone

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Ethylenediamines; Diamines; Polyamines; Amines; Organic Chemicals; Theophylline; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Acetanilides; Anilides; Amides; Aniline Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: After approval of synopsis and approval from Institutional Ethical Review Board (IERB), 50 patients undergoing elective lower abdominopelvic and lower limb surgeries as per inclusion criteria in this study will be enrolled in this study.Two equal groups will be constituted. Informed consent will be taken from all patients after explaining the whole procedure, its merits, demerits, and alternate treatment options. Group A1 (n=25) 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. Group A2 (n=25) will receive Inj. Aminophylline 100mg as slow IV infusion over 30minutes followed by 0.1mg/kg dexamethasone in 100ml Normal saline IV infusion.Drugs will be given in infusion form at the end of the procedure and once daily for 3 days. Coded Drug infusions will be administered by an anesthetist blinded to study groups at the end of the procedure in operation theatre and once daily

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: April 14, 2026
• Study Start: August 1, 2023
• Primary Completion: June 2, 2024
• Study Completion: July 8, 2024
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

PA (1)