Gabapentin, Post-Dural Puncture Headache, Sumatriptan, Theophylline
Conditions
Brief summary
The aim of this study is to compare the safety and efficacy of theophylline, sumatriptan, and gabapentin in the treatment of post-dural puncture headache.
Detailed description
Post-dural puncture headache (PDPH) is a frequent complication of spinal anaesthesia or dural puncture and is an uncomfortable situation for both the patient and the anesthetist. Theophylline as a form of methyl xanthine, is an adenosine receptor antagonist and can decrease intracranial blood flow and venous enlargement. Evidence shows that intravenous theophylline infusion is a rapid, effective, non-invasive, practical, and low-cost method to treat post-spinal headache. Sumatriptan is a selective agonist of 5-hydroxytrytamine-like receptors and is used in the treatment of migraine. It has been used in the treatment of PDPH where it may prevent cerebral vasodilation associated with the cerebrospinal fluid (CSF) leak. Gabapentin is a structural analogue of gamma amino butyric acid; it was used as an anticonvulsant drug for the first time. This drug is now applied in diabetic neuropathy, neuropathic cancer pain and inflammatory injury.
Interventions
DRUGTheophylline
Patients included in this group will receive oral 150 mg theophylline anhydrous tablet (QuibronT/SR, 300 mg dividose tablet, SmithKline Beecham Egypt L.L.C) every 12 hours.
DRUGSumatriptan
Patients included in this group will receive oral 25 mg sumatriptan succinate tablet (Sumigran 25, 25 mg tablet, Sigma pharmaceutical industries, Egypt) every 12 hours.
DRUGGabapentin
Patients included in this group will receive 200 mg of gabapentin every 12 hours.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Age from 21 to 50 years. * Both sexes. * American Society of Anesthesiologists (ASA) physical status ≤ II. * Patient's selection for this study will be based on clinical diagnosis suggesting post-dural puncture headache (PDPH) based on the International Headache Society criteria. * Patients with numeric rating scale (NRS) of ≥ 5.
Exclusion criteria
* Pregnant women. * History of; chronic headache, cluster headache, migraine, convulsions, cerebrovascular accident, and previous neurological diseases. * Signs of meningismus. * Dysrhythmia. * Hypertension. * Ischemic heart disease. * Hyperthyroidism. * Peripheral vascular disease (ischemic colitis). * Liver or renal impairment. * Use of selective serotonin reuptake inhibitors. * Use of ergotamine derivatives in the past 24 hours. * Use of monoamine oxidase inhibitors in the last 2 weeks. * Use of any kind of opiates. * Allergy to the study medications and any contraindication of oral intake.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of headache | 24 hours after drug treatment. | Severity of headache will be assessed using numeric rating scale (NRS) score where 0 = no pain, and 10 = worst possible pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-Dural Puncture Headache duration | 24 hours after drug treatment. | Post-Dural Puncture Headache (PDPH) duration will be recorded from the occurrence of PDPH till numeric rating scale (NRS) score ≤3. |
| Length of hospital stay | Till the discharge from the hospital (Up to 2 weeks) | Length of hospital stay will be recorded from the hospital admission till discharge. |
| Treatment-related side effects | 24 hours after drug treatment. | Treatment-related side effects such as palpitation, dizziness, gastric irritation, nausea/vomiting, diarrhea, warm sensations in the body, tingling sensation, and tightness in the chest, throat, neck, or jaws will be recorded. |
| Total amount of rescue analgesia consumption | 24 hours after drug treatment. | Total amount of rescue analgesia consumption will be measured. |
| Degree of patient satisfaction | 24 hours after drug treatment. | Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied) |
Countries
Egypt
Contacts
CONTACTAsmaa R Eid, MSc
Outcome results
None listed