Clinical trial NCT04257851: Is Theophylline More Effective Than Sumatriptan in the Treatment of Post-dural Puncture Headache
Official title: Is Theophylline More Effective Than Sumatriptan in the Treatment of Post-dural Puncture Headache: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post-Dural Puncture Headache
Keywords: Post-dural puncture headache
Spinal anesthesia
Sumatriptan
Theophylline
Lead sponsor: Damanhour Teaching Hospital
Sponsor class: OTHER_GOV
First posted: 2020-02-06
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Median and Range of Numeric Pain Rating Scale (NPRS) score [(median (range)]
timeFrame: 48 hours after initiation of treatment
measure: Mean and Standard deviation of Numeric Pain Rating Scale (NPRS) score (mean±SD)
timeFrame: 48 hours after initiation of treatment
Secondary outcomes:
measure: Mean and Standard deviation of PDPH duration (hours) (mean±SD)
timeFrame: 48 hours after initiation of treatment
measure: Mean and Standard deviation of Length of hospital stay (days) (mean±SD)
timeFrame: 48 hours after initiation of treatment
measure: Number of participants and Rate of Treatment-related side effects
timeFrame: 48 hours after initiation of treatment
Other outcomes:
Locations:
city: Damanhūr
country: Egypt
facility: Damanhour Teaching Hospital
state: El-Beheira
Study officials:
affiliation: Damanhour Teaching Hospital
name: Ahmed M Shaat, MD
role: PRINCIPAL_INVESTIGATOR
References: