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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


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 At present, the clinical application of theophylline has been replaced by aminophylline and doxofylline, and it is difficult to purchase theophylline in most hospitals in China and other countries.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

pain on the Visual Analogue Scale

Secondary outcome: the overall response to treatment on the Patient Global Impression of Change


Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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