Post-Dural Puncture Headache
Conditions
Brief summary
comparison between oral sumatriptan and Nebulized Dexmedetomidine in Post Dural Puncture Headache in Cesarean Section
Detailed description
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).
Interventions
DRUGPrecedex
Dexmedetomidine (Precedex) is a highly selective alpha 2 adrenoreceptor agonist which produce sedation, anxiolysis, analgesia, and decreasing inflammatory response to anaesthesia and surgical procedure.
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
Sponsors
Fayoum University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. Pregnant female aged between 18 and 40 years old. 2. ASA II and III undergoing elective caesarean section. 3. Diagnosed with Postdural puncture headache with visual analogue score (VAS) ≥ 4 and Lybecker classification score ≥ 2.
Exclusion criteria
1. Patient refusal. 2. History of primary headaches such as migraine, cluster and tension headaches. 3. Hypersensitivity of dexmedetomidine or sumatriptan. 4. Hypertensive disorders of the pregnancy. 5. Contraindication to spinal anesthesia as coagulopathy or infection at site of injection. 6. Symptoms of ischemic heart disease (IHD) e.g. angina. 7. Cerebrovascular disease e.g. stroke or transient ischemic attacks (TIAs). 8. Using of Monoamine oxidase inhibitors (MAOIs) in the last 24h.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| visual analogue scale | First 48 hours | VAS Score from 0 to 10 where score 0 is no headache and 10 is the worst one |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| visual analogue scale | 6 hours. | VAS Score from 0 to 10 where score 0 is no headache and 10 is the worst one |
| Lybecker score | 6 hours | 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 |
Countries
Egypt
Outcome results
None listed