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The aim of this study is to compare between oral prednisolone and oral pregabalin in management of PDPH to detect effectiveness of the treatment in reducing severity of PDPH, total rescue analgesic consumption and adverse effects of prednisolone and pregabalin in patients undergoing lower limb surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group A | Active Comparator | Group A (conservative treatment): oral fluid intake, recumbent positioning, combination of paracetamol and caffeine tablet three times per day for three days (2 tablets of Panadol-Extra tablet, film coated, GlaxoSmithKline Consumer Healthcare Holdings (US) LLC were given every 8hours) and stool softener and to maintain blinding a tablet of vitamins was given twice per day for three days. |
|
| group B | Active Comparator | Group B (oral prednisolone): patients who received conservative treatment as control group together with oral tablet prednisolone 20 mg once daily plus one tablet of vitamins to maintain blinding for three days. |
|
| group C | Active Comparator | Group C (oral pregabalin): patients who received conservative treatment as control group together with oral tablet pregabalin 150 mg twice per day for three days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| caffeine, paracetamol tablet | Drug | oral fluid intake, recumbent positioning, combination of paracetamol and caffeine tablet three times per day for three days (2 tablets of Panadol-Extra tablet, film coated, GlaxoSmithKline Consumer Healthcare Holdings (US) LLC were given every 8hours) and stool softener and to maintain blinding a tablet of vitamins was given twice per day for three days. |
| Measure | Description | Time Frame |
|---|---|---|
| pain intensity of headache | measured by Visual Analogue Scale (VAS) on 0-10 cm scale (0-1 no headache, 2-4 mild headache, 5-7 moderate headache and 8-10 sever headache) | From onset of the headache (0 hour). |
| pain intensity of headache | measured by Visual Analogue Scale (VAS) on 0-10 cm scale (0-1 no headache, 2-4 mild headache, 5-7 moderate headache and 8-10 sever headache) | at 12 hours |
| pain intensity of headache | measured by Visual Analogue Scale (VAS) on 0-10 cm scale (0-1 no headache, 2-4 mild headache, 5-7 moderate headache and 8-10 sever headache) | at 24 hours |
| pain intensity of headache | measured by Visual Analogue Scale (VAS) on 0-10 cm scale (0-1 no headache, 2-4 mild headache, 5-7 moderate headache and 8-10 sever headache) | at 48 hours |
| pain intensity of headache | measured by Visual Analogue Scale (VAS) on 0-10 cm scale (0-1 no headache, 2-4 mild headache, 5-7 moderate headache and 8-10 sever headache) | at 72 hours |
| Headache intensity | modified Lybecker score :1: include patients with mild headache not affecting daily activity with no accompanying symptoms, and oral analgesics work effectively to relieve pain, grade 2: moderate headache that restricts daily activity and leaves the patient in bed for most of the day, injectable analgesia is required to relieve pain, and grade 3: Severe headache with associated symptoms, completely restrict daily activity, with patients kept bed bound for the whole day. |
| Measure | Description | Time Frame |
|---|---|---|
| Associated symptoms of post dural puncture headache | The number of participant who has symptoms of post dural pucture headache as nausea, vomiting, diplopia, dizziness and neck stiffness | for 72 hours |
| Adverse effects of the study drugs e.g. sedation, blurred vision, sleepiness, and dizziness |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dina Salem, MD | faculty of medicine , Zagazig university | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| faculty of medicine, Zagazig university | Zagazig | Egypt |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D051299 | Post-Dural Puncture Headache |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D002110 | Caffeine |
| D000082 | Acetaminophen |
| D011239 | Prednisolone |
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
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Analgesic management of post dural puncture headache: oral prednisolone vs oral pregabalin
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anesthetist not sharing in the study will assess patient
|
| Oral prednisolone | Drug | patients who received conservative treatment as control group together with oral tablet prednisolone 20 mg once daily plus one tablet of vitamins to maintain blinding for three days. . |
|
| oral pregabalin | Drug | patients who received conservative treatment as control group together with oral tablet pregabalin 150 mg twice per day for three days. |
|
| From onset of the headache (0 hour). |
| Headache intensity | modified Lybecker score :1: include patients with mild headache not affecting daily activity with no accompanying symptoms, and oral analgesics work effectively to relieve pain, grade 2: moderate headache that restricts daily activity and leaves the patient in bed for most of the day, injectable analgesia is required to relieve pain, and grade 3: Severe headache with associated symptoms, completely restrict daily activity, with patients kept bed bound for the whole day. | at 12 hours |
| Headache intensity | modified Lybecker score :1: include patients with mild headache not affecting daily activity with no accompanying symptoms, and oral analgesics work effectively to relieve pain, grade 2: moderate headache that restricts daily activity and leaves the patient in bed for most of the day, injectable analgesia is required to relieve pain, and grade 3: Severe headache with associated symptoms, completely restrict daily activity, with patients kept bed bound for the whole day. | at 24 hours |
| Headache intensity | modified Lybecker score :1: include patients with mild headache not affecting daily activity with no accompanying symptoms, and oral analgesics work effectively to relieve pain, grade 2: moderate headache that restricts daily activity and leaves the patient in bed for most of the day, injectable analgesia is required to relieve pain, and grade 3: Severe headache with associated symptoms, completely restrict daily activity, with patients kept bed bound for the whole day. | at 48 hours |
| Headache intensity | modified Lybecker score :1: include patients with mild headache not affecting daily activity with no accompanying symptoms, and oral analgesics work effectively to relieve pain, grade 2: moderate headache that restricts daily activity and leaves the patient in bed for most of the day, injectable analgesia is required to relieve pain, and grade 3: Severe headache with associated symptoms, completely restrict daily activity, with patients kept bed bound for the whole day. | at 72 hours |
In case of sedation, the level will be assessed by using Ramsay Sedation Score (1= anxious or agitated, 2= cooperative and oriented, 3= responds to commands only and 4= brisk response to light tap or loud auditory stimulus) |
| for 72 hours |
| total dose of rescue analgesia | total amount of ketorolac | for 72 hours |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051271 | Headache Disorders, Secondary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |