Is Theophylline More Effective Than Sumatriptan in the Treatment of Post-dural Puncture Headache

Damanhour Teaching Hospital60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Post-Dural Puncture Headache

Interventions

Eligibility

Sex: ALLMin age: 21 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)