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NCT Number: NCT02522013

Aminophylline for Patients With Post-Dural Puncture Headache

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 At present, the clinical application of theophylline has been replaced by aminophylline and doxofylline, and it is difficult to purchase theophylline in most hospitals in China and other countries.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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Suzhou municipal hospital, Suzhou, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aminophylline

Drug

Isotonic saline

Drug

Primary outcomes

  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 outcomes

  1. the overall response to treatment on the Patient Global Impression of Change

    Time frame: 2 days after the Intervention

Other outcomes

  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

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Zhengzhou University

Other

Registry information

Official study title

Aminophylline for Patients With Post-Dural Puncture Headache: a Prospective, Multi-center, Randomized Controlled Trial

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 13, 2015
Registry last updated
Oct 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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