Aminophylline for Patients With Post-Dural Puncture Headache
Status:
Completed
Trial end date:
2016-10-01
Target enrollment:
Participant gender:
Summary
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application of theophylline has been replaced by aminophylline and doxofylline, and it is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.
Phase:
Phase 3
Details
Lead Sponsor:
The First Affiliated Hospital of Zhengzhou University