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Aminophylline for Patients With Post-Dural Puncture Headache

Vetëm përdoruesit e regjistruar mund të përkthejnë artikuj
Identifikohuni Regjistrohu
Lidhja ruhet në kujtesën e fragmenteve
StatusiPërfunduar
Sponsorët
The First Affiliated Hospital of Zhengzhou University

Fjalë kyçe

Abstrakt

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 At present, the clinical application of theophylline has been replaced by aminophylline and doxofylline, and it is difficult to purchase theophylline in most hospitals in China and other countries.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

Datat

Verifikuar së fundmi: 09/30/2016
Paraqitur së pari: 08/07/2015
Regjistrimi i vlerësuar u dorëzua: 08/11/2015
Postuar së pari: 08/12/2015
Përditësimi i fundit i paraqitur: 10/26/2016
Përditësimi i fundit i postuar: 10/30/2016
Data e fillimit të studimit aktual: 09/30/2015
Data e vlerësuar e përfundimit primar: 09/30/2016
Data e vlerësimit të përfundimit të studimit: 09/30/2016

Gjendja ose sëmundja

Post-dural Puncture Headache

Ndërhyrja / trajtimi

Drug: Aminophylline group

Drug: isotonic saline group

Faza

Faza 3

Grupet e krahëve

KrahNdërhyrja / trajtimi
Experimental: Aminophylline group
IV injection of aminophylline
Drug: Aminophylline group
Placebo Comparator: isotonic saline group
IV injection of isotonic saline group
Drug: isotonic saline group

Kriteret e pranimit

Moshat e pranueshme për studim 18 Years Për të 18 Years
Gjinitë e pranueshme për studimAll
Pranon Vullnetarë të Shëndetshëmpo
Kriteret

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.

Rezultati

Masat Kryesore të Rezultateve

1. pain on the Visual Analogue Scale [baseline phase]

2. pain on the Visual Analogue Scale [0.5 hour after the Intervention]

3. pain on the Visual Analogue Scale [1 hour after the Intervention]

4. pain on the Visual Analogue Scale [8 hours after the Intervention]

5. pain on the Visual Analogue Scale [1 day after the Intervention]

6. pain on the Visual Analogue Scale [2 days after the Intervention]

Masat dytësore të rezultateve

1. the overall response to treatment on the Patient Global Impression of Change [2 days after the Intervention]

Masat e tjera të rezultateve

1. safety (occurrence of adverse reactions) [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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