Aminophylline for Patients With Post-Dural Puncture Headache
- Conditions
- Post-dural Puncture Headache
- Interventions
- Drug: isotonic saline
- Registration Number
- NCT02522013
- Lead Sponsor
- The First Affiliated Hospital of Zhengzhou University
- 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 At present, the clinical application of theophylline has been replaced by aminophylline and doxofylline, and it is difficult to purchase theophylline in most hospitals in China and other countries.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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 126
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description isotonic saline group isotonic saline IV injection of isotonic saline group Aminophylline group Aminophylline IV injection of aminophylline
- Primary Outcome Measures
Name Time Method pain on the Visual Analogue Scale 2 days after the Intervention
- Secondary Outcome Measures
Name Time Method the overall response to treatment on the Patient Global Impression of Change 2 days after the Intervention
Trial Locations
- Locations (4)
Henan Province Hospital of Traditional Chinese Medicine
🇨🇳Zhengzhou, Henan, China
Jinzhou central hospital
🇨🇳Jinzhou, Liaoning, China
Suzhou municipal hospital
🇨🇳Suzhou, Anhui, China
the second hospital of Hebei medcial university
🇨🇳Shijiazhuang, Hebei, China