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Aminophylline for Patients With Post-Dural Puncture Headache

Straipsnius versti gali tik registruoti vartotojai
Prisijungti Registracija
Nuoroda įrašoma į mainų sritį
StatusasBaigta
Rėmėjai
The First Affiliated Hospital of Zhengzhou University

Raktažodžiai

Santrauka

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 At present, the clinical application of theophylline has been replaced by aminophylline and doxofylline, and it is difficult to purchase theophylline in most hospitals in China and other countries.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

Datos

Paskutinį kartą patikrinta: 09/30/2016
Pirmasis pateikimas: 08/07/2015
Numatytas registravimas pateiktas: 08/11/2015
Pirmas paskelbtas: 08/12/2015
Paskutinis atnaujinimas pateiktas: 10/26/2016
Paskutinis atnaujinimas paskelbtas: 10/30/2016
Faktinė studijų pradžios data: 09/30/2015
Numatoma pirminio užbaigimo data: 09/30/2016
Numatoma studijų užbaigimo data: 09/30/2016

Būklė ar liga

Post-dural Puncture Headache

Intervencija / gydymas

Drug: Aminophylline group

Drug: isotonic saline group

Fazė

Fazė 3

Rankų grupės

RankaIntervencija / gydymas
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

Tinkamumo kriterijai

Amžius, tinkami studijuoti 18 Years Į 18 Years
Tinkamos studijoms lytysAll
Priima sveikus savanoriusTaip
Kriterijai

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.

Rezultatas

Pirminės rezultatų priemonės

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]

Antrinės rezultatų priemonės

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

Kitos rezultato priemonės

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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