Aminophylline for Patients With Post-Dural Puncture Headache

Study Overview
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Brief Summary
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Post-dural puncture headache (PDPH) is the most common complication of lumbar puncture. Its clinical manifestations are pain in the forehead and the occipital region, or diffuse headache. The pain is dull or fluctuating, becoming worse when standing and better when lying down, and is often accompanied by symptoms including a stiff neck, tinnitus, hearing loss, photophobia, and nausea, which cause great suffering to the patients1. According to epidemiological data, approximately 10% to 30% of the patients who undergo lumbar puncture suffer from PDPH within 48 hours of the procedure.Currently, commonly used treatments for PDPH include rehydration, the administration of corticotropin, caffeine, or sumatriptan, and the application of an epidural blood patch. The efficacy of theophylline has been proven in a placebo-controlled study in which 17 PDPH patients received an intravenous (IV) injection of 200 mg theophylline. The Visual Analogic Scale scores 4 hours after treatment were significantly different compared with those of the placebo group5. At present, the clinical application of theophylline has been replaced by aminophylline and doxofylline, and it is difficult to purchase theophylline in most hospitals in China and other countries. The Aminophylline for Patients With Post-Dural Puncture Headache trial, is a prospective,randomized,double-blind,placebo-controlled trial to evaluate the efficacy and safety of an IV injection of aminophylline on post-dural puncture headache.Eligible patients were randomized in a blinded fashion(1:1) to receive IV injection of aminophyllineor or sterile isotonic saline.The investigators estimate that this trial will demonstrate that an IV injection of aminophylline could be the preferred method for the clinical treatment of PDPH.

Official Title
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Aminophylline for Patients With Post-Dural Puncture Headache: a Prospective, Multi-center, Randomized Controlled Trial

Conditions
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Post-dural Puncture Headache

Intervention / Treatment
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* Drug: Aminophylline
* Drug: isotonic saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: headache has developed after the dural puncture; PDPH was defined according to the International Classification of Headache Disorders III (ICHD-3) criteria; The VAS score of the headache was 5 or more than 5; age between 18 and 70 years old. Exclusion Criteria: a previous history of headache that could interfere with PDPH diagnosis; a history of central nervous system diseases including intracranial hemorrhage, seizures, intracranial hypertension, and hydrocephalus; a history of cardiovascular system diseases including coronary heart disease, arrhythmias, and hypertension; a history of peptic ulcer. women who were pregnant, nursing, or planning a pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aminophylline group<br>IV injection of aminophylline | Drug: Aminophylline<br> <br> |
| Placebo Comparator: isotonic saline group<br>IV injection of isotonic saline group | Drug: isotonic saline<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain on the Visual Analogue Scale |  | baseline phase | 
| pain on the Visual Analogue Scale |  | 0.5 hour after the Intervention | 
| pain on the Visual Analogue Scale |  | 1 hour after the Intervention | 
| pain on the Visual Analogue Scale |  | 8 hours after the Intervention | 
| pain on the Visual Analogue Scale |  | 1 day after the Intervention | 
| pain on the Visual Analogue Scale |  | 2 days after the Intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the overall response to treatment on the Patient Global Impression of Change |  | 2 days after the Intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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post-dural puncture headache, Aminophylline