Post-Dural Puncture Headache
Conditions
Keywords
Post-dural puncture headache, Spinal anesthesia, Sumatriptan, Theophylline
Brief summary
Objectives: To compare the safety and efficacy of oral theophylline versus oral sumatriptan in the treatment of post-dural puncture headache (PDPH). Background: PDPH is the most frequent complication of procedures associated with dural puncture for spinal anesthesia or following accidental dural puncture during epidural anesthesia. Since invasive treatments have known complications, pharmacologic management may be preferable. Patients and Methods: This was a prospective, randomized, double-blind, phase four clinical trial; carried out on 60 patients presented with PDPH at our hospital. Patients were randomly allocated into two equal groups (30 patients each); group T, received oral theophylline, and group S, received oral sumatriptan.
Interventions
DRUGTheophylline Anhydrous Oral Tablet
Theophylline tablet (150 mg/12h)
Sumatriptan tablet (25 mg/12h)
Sponsors
Damanhour Teaching Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Patients with NPRS score of ≥ 5 * American Society of Anesthesiologists (ASA) physical status ≤ II * Age from 21 to 50 years
Exclusion criteria
* Patients with NPRS score \< 5 * ASA physical status \> II * Age \< 21 years or \> 50 years * Pregnant women * History of; Chronic headache, Cluster headache, Migraine * History of; Convulsions, Cerebrovascular accident, Previous neurological diseases * History of peripheral vascular disease (ischemic colitis) * Signs of meningismus * Dysrhythmia * Hypertension * Ischemic heart disease * Hyperthyroidism * Liver or Renal impairment * Use of selective serotonin reuptake inhibitors (SSRIs) * Use of ergotamine derivatives in the past 24 hours * Use of monoamine oxidase inhibitors (MAOIs) in the last two weeks * Use of any kind of opiates * Allergy to the study medications * Any contraindication of oral intake
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median and Range of Numeric Pain Rating Scale (NPRS) score [(median (range)] | 48 hours after initiation of treatment | NPRS measures the severity of PDPH, it is a 11 point scale from 0-10; where 0=No pain and 10=Worst possible pain (before, 2h, 6h, 12h, 18h, 24h, then every 12h till 48h) |
| Mean and Standard deviation of Numeric Pain Rating Scale (NPRS) score (mean±SD) | 48 hours after initiation of treatment | NPRS measures the severity of PDPH, it is a 11 point scale from 0-10; where 0=No pain and 10=Worst possible pain (before, 2h, 6h, 12h, 18h, 24h, then every 12h till 48h) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean and Standard deviation of PDPH duration (hours) (mean±SD) | 48 hours after initiation of treatment | Time from PDPH onset till NPRS score ≤ 3 |
| Mean and Standard deviation of Length of hospital stay (days) (mean±SD) | 48 hours after initiation of treatment | Time from hospital admission till discharge |
| Number of participants and Rate of Treatment-related side effects | 48 hours after initiation of treatment | Number of participants and Rate of: Palpitation, Dizziness, Gastric irritation, Nausea/Vomiting, Diarrhea, Warm sensations in the body, Tingling sensation, and Tightness in the chest, throat, neck, or jaws. |
Countries
Egypt
Outcome results
None listed