Is Theophylline More Effective Than Sumatriptan in the Treatment of Post-dural Puncture Headache
NCT ID: NCT04257851
Last Updated: 2021-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2020-02-15
2021-05-15
Brief Summary
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Background: PDPH is the most frequent complication of procedures associated with dural puncture for spinal anesthesia or following accidental dural puncture during epidural anesthesia. Since invasive treatments have known complications, pharmacologic management may be preferable.
Patients and Methods: This was a prospective, randomized, double-blind, phase four clinical trial; carried out on 60 patients presented with PDPH at our hospital. Patients were randomly allocated into two equal groups (30 patients each); group T, received oral theophylline, and group S, received oral sumatriptan.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Group T (n=30)
Theophylline group
Theophylline Anhydrous Oral Tablet
Theophylline tablet (150 mg/12h)
Group S (n=30)
Sumatriptan group
Sumatriptan Succinate Oral Tablet
Sumatriptan tablet (25 mg/12h)
Interventions
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Theophylline Anhydrous Oral Tablet
Theophylline tablet (150 mg/12h)
Sumatriptan Succinate Oral Tablet
Sumatriptan tablet (25 mg/12h)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiologists (ASA) physical status ≤ II
* Age from 21 to 50 years
Exclusion Criteria
* ASA physical status \> II
* Age \< 21 years or \> 50 years
* Pregnant women
* History of; Chronic headache, Cluster headache, Migraine
* History of; Convulsions, Cerebrovascular accident, Previous neurological diseases
* History of peripheral vascular disease (ischemic colitis)
* Signs of meningismus
* Dysrhythmia
* Hypertension
* Ischemic heart disease
* Hyperthyroidism
* Liver or Renal impairment
* Use of selective serotonin reuptake inhibitors (SSRIs)
* Use of ergotamine derivatives in the past 24 hours
* Use of monoamine oxidase inhibitors (MAOIs) in the last two weeks
* Use of any kind of opiates
* Allergy to the study medications
* Any contraindication of oral intake
21 Years
50 Years
ALL
No
Sponsors
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Damanhour Teaching Hospital
OTHER_GOV
Responsible Party
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Principal Investigators
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Ahmed M Shaat, MD
Role: PRINCIPAL_INVESTIGATOR
Damanhour Teaching Hospital
Locations
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Damanhour Teaching Hospital
Damanhūr, El-Beheira, Egypt
Countries
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Other Identifiers
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DTH: 20001
Identifier Type: -
Identifier Source: org_study_id
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