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comparison between oral sumatriptan and Nebulized Dexmedetomidine in Post Dural Puncture Headache in Cesarean Section
A total of 48 patients will be randomly chosen to receive either inhaled dexmedetomidine (Group D, n= 24) or oral sumatriptan (Group S, n= 24) by a random sequence number generated by the computer kept in sealed envelopes. Those envelopes will be opened once the patient is recruited and participants will receive either inhaled dexmedetomidine or oral sumatriptan as per the envelope. Data collectors will be blinded to the type of used medication (Dexmedetomidine or Sumatriptan).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Precedex group | Active Comparator | 1- Inhaled Dexmedetomidine group (Group D, n= 24): will receive nebulization of 1 µg/kg dexmedetomidine (Precedex, Dexmedetomidine HCl 100 µg/mL, Pfizer Inc.) diluted in 4 mL 0.9% saline twice daily starting from the PDPH diagnosis time. The intervention will be continued until achieving a VAS score ≤ 3 and Lybecker classification score < 2 or for a maximum of 48 hours when occurrence of side effects in form of hypotension, bradycardia, nausea stop the medication and give supportive treatment. |
|
| Sumatriptan group | Active Comparator | 2- Oral sumatriptan group (Group S, n= 24): sumatriptan 25 mg every 8 hours orally when occurrence of side effects in form of paresthesia, dizziness and chest tightness stop the medication. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Precedex | Drug | Dexmedetomidine (Precedex) is a highly selective alpha 2 adrenoreceptor agonist which produce sedation, anxiolysis, analgesia, and decreasing inflammatory response to anaesthesia and surgical procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| visual analogue scale | VAS Score from 0 to 10 where score 0 is no headache and 10 is the worst one | First 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| visual analogue scale | VAS Score from 0 to 10 where score 0 is no headache and 10 is the worst one | 6 hours. |
| visual analogue scale | VAS Score from 0 to 10 where score 0 is no headache and 10 is the worst one |
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Inclusion criteria:
Exclusion criteria:
Pregnant female
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed A Hamed, MD | Faculty of medicine,Fayoum University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fayoum University hospital | El Fayoum Qesm | Faiyum Governorate | 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 |
|---|---|
| D020927 | Dexmedetomidine |
| D018170 | Sumatriptan |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Sumatriptan 25 mg | Drug | Sumatriptan (Imigran) is a selective serotonin receptor agonist. It works by narrowing blood vessels in the brain, stopping pain signals from being sent to the brain, and blocking the release of certain natural substances that cause pain (as substance -p), nausea, and other symptoms of migraine |
|
| 12 hours. |
| visual analogue scale | VAS Score from 0 to 10 where score 0 is no headache and 10 is the worst one | 18 hours. |
| visual analogue scale | VAS Score from 0 to 10 where score 0 is no headache and 10 is the worst one | 24 hours. |
| visual analogue scale | VAS Score from 0 to 10 where score 0 is no headache and 10 is the worst one | 30 hours. |
| visual analogue scale | VAS Score from 0 to 10 where score 0 is no headache and 10 is the worst one | 36 hours. |
| visual analogue scale | VAS Score from 0 to 10 where score 0 is no headache and 10 is the worst one | 42 hours. |
| Lybecker score | Mild Mild:Daily activities slightly restricted. Patient is not bedridden No associated symptoms Moderate:Daily activities significantly restricted and most of the day patient is bedridden with or without associated symptoms Severe:Daily activities completely restricted, patient is bedridden all the day and always with associated symptoms | 6 hours |
| Lybecker score | Mild Mild:Daily activities slightly restricted. Patient is not bedridden No associated symptoms Moderate:Daily activities significantly restricted and most of the day patient is bedridden with or without associated symptoms Severe:Daily activities completely restricted, patient is bedridden all the day and always with associated symptoms | 12 hours |
| Lybecker score | Mild Mild:Daily activities slightly restricted. Patient is not bedridden No associated symptoms Moderate:Daily activities significantly restricted and most of the day patient is bedridden with or without associated symptoms Severe:Daily activities completely restricted, patient is bedridden all the day and always with associated symptoms | 18 hours |
| Lybecker score | Mild Mild:Daily activities slightly restricted. Patient is not bedridden No associated symptoms Moderate:Daily activities significantly restricted and most of the day patient is bedridden with or without associated symptoms Severe:Daily activities completely restricted, patient is bedridden all the day and always with associated symptoms | 24 hours |
| Lybecker score | Mild Mild:Daily activities slightly restricted. Patient is not bedridden No associated symptoms Moderate:Daily activities significantly restricted and most of the day patient is bedridden with or without associated symptoms Severe:Daily activities completely restricted, patient is bedridden all the day and always with associated symptoms | 30 hours |
| Lybecker score | Mild Mild:Daily activities slightly restricted. Patient is not bedridden No associated symptoms Moderate:Daily activities significantly restricted and most of the day patient is bedridden with or without associated symptoms Severe:Daily activities completely restricted, patient is bedridden all the day and always with associated symptoms | 36 hours |
| D009422 | Nervous System Diseases |
| D013449 |
| Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |