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Objectives: To compare the safety and efficacy of oral theophylline versus oral sumatriptan in the treatment of post-dural puncture headache (PDPH).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group T (n=30) | Active Comparator | Theophylline group |
|
| Group S (n=30) | Active Comparator | Sumatriptan group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Theophylline Anhydrous Oral Tablet | Drug | Theophylline tablet (150 mg/12h) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Median and Range of Numeric Pain Rating Scale (NPRS) score [(median (range)] | NPRS measures the severity of PDPH, it is a 11 point scale from 0-10; where 0=No pain and 10=Worst possible pain (before, 2h, 6h, 12h, 18h, 24h, then every 12h till 48h) | 48 hours after initiation of treatment |
| Mean and Standard deviation of Numeric Pain Rating Scale (NPRS) score (mean±SD) | NPRS measures the severity of PDPH, it is a 11 point scale from 0-10; where 0=No pain and 10=Worst possible pain (before, 2h, 6h, 12h, 18h, 24h, then every 12h till 48h) | 48 hours after initiation of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Mean and Standard deviation of PDPH duration (hours) (mean±SD) | Time from PDPH onset till NPRS score ≤ 3 | 48 hours after initiation of treatment |
| Mean and Standard deviation of Length of hospital stay (days) (mean±SD) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed M Shaat, MD | Damanhour Teaching Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Damanhour Teaching Hospital | Damanhūr | El-Beheira | Egypt |
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| ID | Term |
|---|---|
| D051299 | Post-Dural Puncture Headache |
| ID | Term |
|---|---|
| D051271 | Headache Disorders, Secondary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D013806 | Theophylline |
| D018170 | Sumatriptan |
| ID | Term |
|---|---|
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
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| Sumatriptan Succinate Oral Tablet | Drug | Sumatriptan tablet (25 mg/12h) |
|
|
Time from hospital admission till discharge
| 48 hours after initiation of treatment |
| Number of participants and Rate of Treatment-related side effects | Number of participants and Rate of: Palpitation, Dizziness, Gastric irritation, Nausea/Vomiting, Diarrhea, Warm sensations in the body, Tingling sensation, and Tightness in the chest, throat, neck, or jaws. | 48 hours after initiation of treatment |
| D009422 | Nervous System Diseases |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D014363 | Tryptamines |
| D007211 | Indoles |