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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04257851
Other study ID # DTH: 20001
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date February 15, 2020
Est. completion date May 15, 2021

Study information

Verified date February 2020
Source Damanhour Teaching Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date May 15, 2021
Est. primary completion date May 15, 2021
Accepts healthy volunteers No
Gender All
Age group 21 Years to 50 Years
Eligibility 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

Study Design


Intervention

Drug:
Theophylline Anhydrous Oral Tablet
Theophylline tablet (150 mg/12h)
Sumatriptan Succinate Oral Tablet
Sumatriptan tablet (25 mg/12h)

Locations

Country Name City State
Egypt Damanhour Teaching Hospital Damanhur El-Beheira

Sponsors (1)

Lead Sponsor Collaborator
Damanhour Teaching Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Median and Range of Numeric Pain Rating Scale (NPRS) score [(median (range)] 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) 48 hours after initiation of treatment
Primary Mean and Standard deviation of Numeric Pain Rating Scale (NPRS) score (mean±SD) 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) 48 hours after initiation of treatment
Secondary Mean and Standard deviation of PDPH duration (hours) (mean±SD) Time from PDPH onset till NPRS score = 3 48 hours after initiation of treatment
Secondary Mean and Standard deviation of Length of hospital stay (days) (mean±SD) Time from hospital admission till discharge 48 hours after initiation of treatment
Secondary Number of participants and Rate of Treatment-related side effects 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. 48 hours after initiation of treatment
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