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Objectives: To compare the safety and efficacy of IV aminophylline versus IV neostigmine/atropine mixture 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 A, received IV aminophylline, and group NA, received IV neostigmine/atropine mixture.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (n=30) | Active Comparator | Aminophylline group |
|
| Group NA (n=30) | Active Comparator | Neostigmine/Atropine group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV Aminophylline | Drug | IV Aminophylline (100 mg/8h) |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Median and Range of Numeric Pain Rating Scale (NPRS) score | 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, 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 |
| Number of participants and Rate of Treatment-related complications |
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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 |
|---|---|
| D000628 | Aminophylline |
| D009388 | Neostigmine |
| D001285 | Atropine |
| ID | Term |
|---|---|
| D005029 | Ethylenediamines |
| D003959 | Diamines |
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 |
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| IV Neostigmine Methylsulfate + Atropine Sulphate | Drug | IV Neostigmine/Atropine mixture (20 μg/kg Neostigmine + 10 μg/kg Atropine)/8h |
|
|
Number of participants and Rate of: Diarrhea, Palpitation, Abdominal cramps, Muscle twitches, Bronchospasm, Urinary bladder hyperactivity
| 48 hours after initiation of treatment |
| D009422 | Nervous System Diseases |
| Organic Chemicals |
| D013806 | Theophylline |
| D014970 | Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D050338 | Phenylammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D009861 | Onium Compounds |
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |