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Aminophylline for Patients With Post-Dural Puncture Headache

NCT ID: NCT02522013

Last Updated: 2016-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-10-31

Brief Summary

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 At present, the clinical application of theophylline has been replaced by aminophylline and doxofylline, and it is difficult to purchase theophylline in most hospitals in China and other countries.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

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Conditions

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Post-dural Puncture Headache

Keywords

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post-dural puncture headache Aminophylline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Aminophylline group

IV injection of aminophylline

Group Type EXPERIMENTAL

Aminophylline

Intervention Type DRUG

isotonic saline group

IV injection of isotonic saline group

Group Type PLACEBO_COMPARATOR

isotonic saline

Intervention Type DRUG

Interventions

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Aminophylline

Intervention Type DRUG

isotonic saline

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role lead

Responsible Party

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Chuanjie Wu

The First Affiliated Hospital of Zhengzhou University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fang Xue, MD

Role: PRINCIPAL_INVESTIGATOR

the second hospital of Hebei medcial university

Dongsheng Guan, MD

Role: PRINCIPAL_INVESTIGATOR

Henan Province Hospital of Traditional Chinese Medicine

Changming Wan, MD

Role: PRINCIPAL_INVESTIGATOR

Jingzhou Central Hospital

Zhengfei Ma, MD

Role: PRINCIPAL_INVESTIGATOR

Suzhou Municipal Hospital

Locations

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Suzhou municipal hospital

Suzhou, Anhui, China

Site Status

the second hospital of Hebei medcial university

Shijiazhuang, Hebei, China

Site Status

Henan Province Hospital of Traditional Chinese Medicine

Zhengzhou, Henan, China

Site Status

Jinzhou central hospital

Jinzhou, Liaoning, China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 3517473 (View on PubMed)

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.

Reference Type RESULT
PMID: 24711606 (View on PubMed)

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.

Reference Type RESULT
PMID: 3929052 (View on PubMed)

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.

Reference Type RESULT
PMID: 22941478 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29572284 (View on PubMed)

Other Identifiers

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FAHZZU-166

Identifier Type: -

Identifier Source: org_study_id