Aminophylline for Patients With Post-Dural Puncture Headache

Zhengzhou University

Status and phase

Completed

Phase 3

Conditions

Post-dural Puncture Headache

Treatments

Drug: Aminophylline

Drug: isotonic saline

Study type

Interventional

Funder types

Other

Identifiers

NCT02522013

FAHZZU-166

Details and patient eligibility

About

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 At present, the clinical application of theophylline has been replaced by aminophylline and doxofylline, and it is difficult to purchase theophylline in most hospitals in China and other countries.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.

Enrollment

126 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.