Clinical Trial: Aminophylline for Patients With Post-Dural Puncture Headache

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 At present, the clinical application of theophylline has been replaced by aminophylline and doxofylline, and it is difficult to purchase theophylline in most hospitals in China and other countries.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


Detailed Summary:
Sponsor: The First Affiliated Hospital of Zhengzhou University

Current Primary Outcome:

  • pain on the Visual Analogue Scale [ Time Frame: baseline phase ]
  • pain on the Visual Analogue Scale [ Time Frame: 0.5 hour after the Intervention ]
  • pain on the Visual Analogue Scale [ Time Frame: 1 hour after the Intervention ]
  • pain on the Visual Analogue Scale [ Time Frame: 8 hours after the Intervention ]
  • pain on the Visual Analogue Scale [ Time Frame: 1 day after the Intervention ]
  • pain on the Visual Analogue Scale [ Time Frame: 2 days after the Intervention ]


Original Primary Outcome: Same as current

Current Secondary Outcome: the overall response to treatment on the Patient Global Impression of Change [ Time Frame: 2 days after the Intervention ]

Original Secondary Outcome: Same as current

Information By: The First Affiliated Hospital of Zhengzhou University

Dates:
Date Received: August 8, 2015
Date Started: October 2015
Date Completion:
Last Updated: October 27, 2016
Last Verified: October 2016