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Aminophylline for Patients With Post-Dural Puncture Headache

Primary Purpose

Post-dural Puncture Headache

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Aminophylline
isotonic saline
Sponsored by
The First Affiliated Hospital of Zhengzhou University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-dural Puncture Headache focused on measuring post-dural puncture headache, Aminophylline

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Suzhou municipal hospital
  • the second hospital of Hebei medcial university
  • Henan Province Hospital of Traditional Chinese Medicine
  • Jinzhou central hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Aminophylline group

isotonic saline group

Arm Description

IV injection of aminophylline

IV injection of isotonic saline group

Outcomes

Primary Outcome Measures

pain on the Visual Analogue Scale
pain on the Visual Analogue Scale
pain on the Visual Analogue Scale
pain on the Visual Analogue Scale
pain on the Visual Analogue Scale
pain on the Visual Analogue Scale

Secondary Outcome Measures

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

Full Information

First Posted
August 8, 2015
Last Updated
October 27, 2016
Sponsor
The First Affiliated Hospital of Zhengzhou University
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1. Study Identification

Unique Protocol Identification Number
NCT02522013
Brief Title
Aminophylline for Patients With Post-Dural Puncture Headache
Official Title
Aminophylline for Patients With Post-Dural Puncture Headache: a Prospective, Multi-center, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Zhengzhou University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-dural Puncture Headache
Keywords
post-dural puncture headache, Aminophylline

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aminophylline group
Arm Type
Experimental
Arm Description
IV injection of aminophylline
Arm Title
isotonic saline group
Arm Type
Placebo Comparator
Arm Description
IV injection of isotonic saline group
Intervention Type
Drug
Intervention Name(s)
Aminophylline
Intervention Type
Drug
Intervention Name(s)
isotonic saline
Primary Outcome Measure Information:
Title
pain on the Visual Analogue Scale
Time Frame
baseline phase
Title
pain on the Visual Analogue Scale
Time Frame
0.5 hour after the Intervention
Title
pain on the Visual Analogue Scale
Time Frame
1 hour after the Intervention
Title
pain on the Visual Analogue Scale
Time Frame
8 hours after the Intervention
Title
pain on the Visual Analogue Scale
Time Frame
1 day after the Intervention
Title
pain on the Visual Analogue Scale
Time Frame
2 days after the Intervention
Secondary Outcome Measure Information:
Title
the overall response to treatment on the Patient Global Impression of Change
Time Frame
2 days after the Intervention
Other Pre-specified Outcome Measures:
Title
safety (occurrence of adverse reactions)
Description
The safety of the IV aminophylline treatment for PDPH was evaluated based on the occurrence of adverse reactions
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fang Xue, MD
Organizational Affiliation
the second hospital of Hebei medcial university
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dongsheng Guan, MD
Organizational Affiliation
Henan Province Hospital of Traditional Chinese Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Changming Wan, MD
Organizational Affiliation
Jingzhou Central Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zhengfei Ma, MD
Organizational Affiliation
Suzhou Municipal Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Suzhou municipal hospital
City
Suzhou
State/Province
Anhui
Country
China
Facility Name
the second hospital of Hebei medcial university
City
Shijiazhuang
State/Province
Hebei
Country
China
Facility Name
Henan Province Hospital of Traditional Chinese Medicine
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
Jinzhou central hospital
City
Jinzhou
State/Province
Liaoning
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
3517473
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. doi: 10.1007/BF01711650.
Results Reference
result
PubMed Identifier
24711606
Citation
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.
Results Reference
result
PubMed Identifier
3929052
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. doi: 10.1118/1.595674.
Results Reference
result
PubMed Identifier
22941478
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.
Results Reference
result
PubMed Identifier
29572284
Citation
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.
Results Reference
derived

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Aminophylline for Patients With Post-Dural Puncture Headache

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