Aminophylline for Patients With Post-Dural Puncture Headache
Information source: The First Affiliated Hospital of Zhengzhou University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Post-dural Puncture Headache
Intervention: Aminophylline (Drug); isotonic saline (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: The First Affiliated Hospital of Zhengzhou University Official(s) and/or principal investigator(s): Fang Xue, MD, Principal Investigator, Affiliation: the second hospital of Hebei medcial university Dongsheng Guan, MD, Principal Investigator, Affiliation: Henan Province Hospital of Traditional Chinese Medicine Changming Wan, MD, Principal Investigator, Affiliation: Jinzhou central hospital Zhengfei Ma, MD, Principal Investigator, Affiliation: Suzhou municipal hospital
Overall contact: Yajun Lian, MD, Phone: 13838367143, Email: lianyajun369@yahoo.com
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application of theophylline has been replaced by aminophylline and doxofylline, and it is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.
Clinical Details
Official title: Aminophylline for Patients With Post-Dural Puncture Headache: a Prospective, Multi-center, Randomized Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: pain on the Visual Analogue Scalepain on the Visual Analogue Scale pain on the Visual Analogue Scale pain on the Visual Analogue Scale pain on the Visual Analogue Scale pain on the Visual Analogue Scale
Secondary outcome: the overall response to treatment on the Patient Global Impression of Change
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Yajun Lian, MD, Phone: 13838367143, Email: lianyajun369@yahoo.com Additional Information
Starting date: October 2015
Last updated: August 12, 2015
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