Clinical trial NCT02522013: Aminophylline for Patients With Post-Dural Puncture Headache
Official title: Aminophylline for Patients With Post-Dural Puncture Headache: a Prospective, Multi-center, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post-dural Puncture Headache
Keywords: post-dural puncture headache
Aminophylline
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2015-08-13
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 At present, the clinical application of theophylline has been replaced by aminophylline and doxofylline, and it is difficult to purchase theophylline in most hospitals in China and other countries.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


Eligibility 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.

Primary outcomes:
measure: pain on the Visual Analogue Scale
timeFrame: baseline phase
measure: pain on the Visual Analogue Scale
timeFrame: 0.5 hour after the Intervention
measure: pain on the Visual Analogue Scale
timeFrame: 1 hour after the Intervention
measure: pain on the Visual Analogue Scale
timeFrame: 8 hours after the Intervention
measure: pain on the Visual Analogue Scale
timeFrame: 1 day after the Intervention
measure: pain on the Visual Analogue Scale
timeFrame: 2 days after the Intervention
Secondary outcomes:
measure: the overall response to treatment on the Patient Global Impression of Change
timeFrame: 2 days after the Intervention
Other outcomes:
measure: safety (occurrence of adverse reactions)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Locations:
city: Suzhou
country: China
facility: Suzhou municipal hospital
state: Anhui
city: Shijiazhuang
country: China
facility: the second hospital of Hebei medcial university
state: Hebei
city: Zhengzhou
country: China
facility: Henan Province Hospital of Traditional Chinese Medicine
state: Henan
city: Jinzhou
country: China
facility: Jinzhou central hospital
state: Liaoning
Study officials:
affiliation: the second hospital of Hebei medcial university
name: Fang Xue, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Henan Province Hospital of Traditional Chinese Medicine
name: Dongsheng Guan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jingzhou Central Hospital
name: Changming Wan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Suzhou Municipal Hospital
name: Zhengfei Ma, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Feuerstein TJ, Zeides A. Theophylline relieves headache following lumbar puncture. Placebo-controlled, double-blind pilot study. Klin Wochenschr. 1986 Mar 3;64(5):216-8. doi: 10.1007/BF01711650.
citation: Arroyo-Quiroz C, Kurth T, Cantu-Brito C, Lopez-Ridaura R, Romieu I, Lajous M. Lifetime prevalence and underdiagnosis of migraine in a population sample of Mexican women. Cephalalgia. 2014 Nov;34(13):1088-92. doi: 10.1177/0333102414529196. Epub 2014 Apr 7.
citation: Mills MD, Hogstrom KR, Fields RS. Determination of electron beam output factors for a 20-MeV linear accelerator. Med Phys. 1985 Jul-Aug;12(4):473-6. doi: 10.1118/1.595674.
citation: Hayallah AK, Talhouni AA, Alim AA. Design and synthesis of new 8-anilide theophylline derivatives as bronchodilators and antibacterial agents. Arch Pharm Res. 2012 Aug;35(8):1355-68. doi: 10.1007/s12272-012-0805-4. Epub 2012 Sep 1.
citation: Wu C, Guan D, Ren M, Ma Z, Wan C, Cui Y, Zhong P, Zhao W, Li C, Yan F, Xie J, Xue F, Lian Y, Liu H, Wang C, Ji X, Xie N. Aminophylline for treatment of postdural puncture headache: A randomized clinical trial. Neurology. 2018 Apr 24;90(17):e1523-e1529. doi: 10.1212/WNL.0000000000005351. Epub 2018 Mar 23.