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Aminophylline for Patients With Post-Dural Puncture Headache

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ClinicalTrials.gov Identifier: NCT02522013
Recruitment Status : Completed
First Posted : August 13, 2015
Last Update Posted : October 31, 2016
Sponsor:
Information provided by (Responsible Party):
Chuanjie Wu, 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 At present, the clinical application of theophylline has been replaced by aminophylline and doxofylline, and it is difficult to purchase theophylline in most hospitals in China and other countries.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.


Condition or disease Intervention/treatment Phase
Post-dural Puncture Headache Drug: Aminophylline Drug: isotonic saline Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Aminophylline for Patients With Post-Dural Puncture Headache: a Prospective, Multi-center, Randomized Controlled Trial
Study Start Date : October 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
Experimental: Aminophylline group
IV injection of aminophylline
Drug: Aminophylline
Placebo Comparator: isotonic saline group
IV injection of isotonic saline group
Drug: isotonic saline



Primary Outcome Measures :
  1. pain on the Visual Analogue Scale [ Time Frame: baseline phase ]
  2. pain on the Visual Analogue Scale [ Time Frame: 0.5 hour after the Intervention ]
  3. pain on the Visual Analogue Scale [ Time Frame: 1 hour after the Intervention ]
  4. pain on the Visual Analogue Scale [ Time Frame: 8 hours after the Intervention ]
  5. pain on the Visual Analogue Scale [ Time Frame: 1 day after the Intervention ]
  6. pain on the Visual Analogue Scale [ Time Frame: 2 days after the Intervention ]

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

Other Outcome Measures:
  1. safety (occurrence of adverse reactions) [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days ]
    The safety of the IV aminophylline treatment for PDPH was evaluated based on the occurrence of adverse reactions



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02522013


Locations
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China, Anhui
Suzhou municipal hospital
Suzhou, Anhui, China
China, Hebei
the second hospital of Hebei medcial university
Shijiazhuang, Hebei, China
China, Henan
Henan Province Hospital of Traditional Chinese Medicine
Zhengzhou, Henan, China
China, Liaoning
Jinzhou central hospital
Jinzhou, Liaoning, China
Sponsors and Collaborators
The First Affiliated Hospital of Zhengzhou University
Investigators
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Principal Investigator: Fang Xue, MD the second hospital of Hebei medcial university
Principal Investigator: Dongsheng Guan, MD Henan Province Hospital of Traditional Chinese Medicine
Principal Investigator: Changming Wan, MD Jingzhou Central Hospital
Principal Investigator: Zhengfei Ma, MD Suzhou Municipal Hospital
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chuanjie Wu, The First Affiliated Hospital of Zhengzhou University
ClinicalTrials.gov Identifier: NCT02522013    
Other Study ID Numbers: FAHZZU-166
First Posted: August 13, 2015    Key Record Dates
Last Update Posted: October 31, 2016
Last Verified: October 2016
Keywords provided by Chuanjie Wu, The First Affiliated Hospital of Zhengzhou University:
post-dural puncture headache
Aminophylline
Additional relevant MeSH terms:
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Post-Dural Puncture Headache
Headache
Wounds and Injuries
Pain
Neurologic Manifestations
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Aminophylline
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cardiotonic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Protective Agents