Aminophylline for Patients With Post-Dural Puncture Headache

Post-dural Puncture Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02522013
• Other study ID #: FAHZZU-166
• Status: Completed
• Phase: Phase 3
• First received: August 8, 2015
• Last updated: October 27, 2016
• Start date: October 2015
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: The First Affiliated Hospital of Zhengzhou University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

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 At present, the clinical application of theophylline has been replaced by aminophylline and doxofylline, and it is difficult to purchase theophylline in most hospitals in China and other countries.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Headache
• Post-dural Puncture Headache
• Wounds and Injuries

Intervention

Drug:
• Aminophylline

• isotonic saline

Locations

Country	Name	City	State
China	Jinzhou central hospital	Jinzhou	Liaoning
China	the second hospital of Hebei medcial university	Shijiazhuang	Hebei
China	Suzhou municipal hospital	Suzhou	Anhui
China	Henan Province Hospital of Traditional Chinese Medicine	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Zhengzhou University

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	safety (occurrence of adverse reactions)	The safety of the IV aminophylline treatment for PDPH was evaluated based on the occurrence of adverse reactions	Participants will be followed for the duration of hospital stay, an expected average of 7 days	Yes
Primary	pain on the Visual Analogue Scale		baseline phase	No
Primary	pain on the Visual Analogue Scale		0.5 hour after the Intervention	No
Primary	pain on the Visual Analogue Scale		1 hour after the Intervention	No
Primary	pain on the Visual Analogue Scale		8 hours after the Intervention	No
Primary	pain on the Visual Analogue Scale		1 day after the Intervention	No
Primary	pain on the Visual Analogue Scale		2 days after the Intervention	No
Secondary	the overall response to treatment on the Patient Global Impression of Change		2 days after the Intervention	No