A Phase 4 interventional study of Pregabalin 100Mg Oral Cap and Hydrocortisone in Post-Dural Puncture Headache, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2019-11-12.
Sponsored by Cairo University · Phase 4, Interventional, and Treatment
Postdural puncture headache (PDPH) is a common complication after spinal anesthesia. The role of pregabalin and hydrocortisone in the treatment of PDPH is unclear. The aim of this work is to assess and compare the efficacy of both drugs in severe cases of PDPH after spinal anesthesia for elective cesarean section.
The study will be done on 30 patient with PDPH with VAS score ≥ 5 after spinal anesthesia for elective cesarean section. Patients will be divided into three groups: Control group (group C):will receive conventional treatment in the form of good oral hydration, 500 mg of acetaminophen plus 65 mg of caffeine oral tablets thrice daily, 3 cups of coffee daily, 50 mg of diclofenac potassium oral tablets twice daily and recumbent positioning for 48 hours. Pregabalin group (group P): will receive the conventional treatment plus 100 mg of pregabalin oral tablet every 8 hours for 48 hours. Hydrocortisone group (group H): will receive the conventional treatment plus 100 mg of hydrocortisone IV every 8 hours for 48 hours. The three groups will be compared regarding the headache intensity using a visual analog scale.
125 studies on the registry are indexed under Post-Dural Puncture Headache; 25 are open to participants now.
This study's enrollment of 30 is below the median of 80 across 82 interventional studies indexed under Post-Dural Puncture Headache.
Browse Post-Dural Puncture Headache studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
received conventional treatment in the form of good oral hydration, 500 mg of acetaminophen plus 65 mg of caffeine oral tablets thrice daily, 3 cups of coffee daily, 50 mg of diclofenac potassium oral tablets twice daily and recumbent positioning for 48 hours
Drug: Acetaminophen · Other: oral fluids · Drug: Caffeine · Drug: Diclofenac
received the conventional treatment plus 100 mg of pregabalin oral tablet every 8 hours for 48 hours
Drug: Pregabalin 100Mg Oral Cap · Drug: Acetaminophen · Other: oral fluids · Drug: Caffeine · Drug: Diclofenac
received the conventional treatment plus 100 mg of hydrocortisone IV every 8 hours for 48 hours.
Drug: Hydrocortisone · Drug: Acetaminophen · Other: oral fluids · Drug: Caffeine · Drug: Diclofenac
giving a drug to relieve post-dural puncture headache
Giving drug to relieve post-dural puncture headache
giving a drug to relieve post-dural puncture headache
Also known as: Paracetamol
giving oral fluids to maintain good hydration
Also known as: good hydration
giving a drug to relieve post-dural puncture headache
giving a drug to relieve post-dural puncture headache
Assessment of pain using Visual Analogue Scale
Headache intensity after 1 minute in upright position using the Visual Analogue Scale for pain assessment ranging from 0 to 10, with zero means no pain and 10 is the worst pain after 48 hours of treatment
Time frame: the first 48 hours following treatment
Assessment of the amount of rescue drug
Total dose of nalbuphine given in each group..
Time frame: The first 48 hours following treatment
incidence of side effects of the studied drug
incidence of Somnolence
Time frame: the first 48 hours following treatment
incidence of side effect of the studied drug
incidence of dizziness
Time frame: the first 48 hours following treatment
Plan to share: No
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This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Cairo University