Aminophylline for Patients With Post-Dural Puncture Headache

NCT02522013 | Completed Phase 3 DMC

• 1 other identifier: FAHZZU-166
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 4

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 At present, the clinical application of theophylline has been replaced by aminophylline and doxofylline, and it is difficult to purchase theophylline in most hospitals in China and other countries.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

Conditions

Post-dural Puncture Headache

Keywords

post-dural puncture headache; Aminophylline

Outcome Measures

Primary Outcomes (6)

• pain on the Visual Analogue Scale

  baseline phase

• pain on the Visual Analogue Scale

  0.5 hour after the Intervention

• pain on the Visual Analogue Scale

  1 hour after the Intervention

• pain on the Visual Analogue Scale

  8 hours after the Intervention

• pain on the Visual Analogue Scale

  1 day after the Intervention

• pain on the Visual Analogue Scale

  2 days after the Intervention

Secondary Outcomes (1)

• the overall response to treatment on the Patient Global Impression of Change

  2 days after the Intervention

Other Outcomes (1)

• safety (occurrence of adverse reactions)

  Participants will be followed for the duration of hospital stay, an expected average of 7 days

Study Arms (2)

Aminophylline group

EXPERIMENTAL

IV injection of aminophylline

Drug: Aminophylline

isotonic saline group

PLACEBO COMPARATOR

IV injection of isotonic saline group

Drug: isotonic saline

Interventions

Aminophylline DRUG

Aminophylline group

isotonic saline DRUG

isotonic saline group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead

Study Sites (4)

Suzhou municipal hospital

Suzhou, Anhui, China

Location

the second hospital of Hebei medcial university

Shijiazhuang, Hebei, China

Location

Henan Province Hospital of Traditional Chinese Medicine

Zhengzhou, Henan, China

Location

Jinzhou central hospital

Jinzhou, Liaoning, China

Location

Related Publications (5)

• 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.

  PMID: 3517473 RESULT

• 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.

  PMID: 24711606 RESULT

• 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.

  PMID: 3929052 RESULT

• 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.

  PMID: 22941478 RESULT

• 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.

  PMID: 29572284 DERIVED

MeSH Terms

Conditions

Post-Dural Puncture Headache

Interventions

Aminophylline; Sodium Chloride

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Ethylenediamines; Diamines; Polyamines; Amines; Organic Chemicals; Theophylline; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Fang Xue, MD

  the second hospital of Hebei medcial university

  PRINCIPAL INVESTIGATOR

• Dongsheng Guan, MD

  Henan Province Hospital of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

• Changming Wan, MD

  Jingzhou Central Hospital

  PRINCIPAL INVESTIGATOR

• Zhengfei Ma, MD

  Suzhou Municipal Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The First Affiliated Hospital of Zhengzhou University

Study Record Dates

• First Submitted: August 8, 2015
• First Posted: August 13, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 31, 2016

Record last verified: 2016-10

Locations

CN (4)