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

Damanhour Teaching Hospital

Status and phase: Completed; Phase 4

Conditions: Post-Dural Puncture Headache

Treatments: Drug: Sumatriptan Succinate Oral Tablet; Drug: Theophylline Anhydrous Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04257851

DTH: 20001

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 21 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Group T (n=30)

Active Comparator group

Description:

Theophylline group

Treatment:

Drug: Theophylline Anhydrous Oral Tablet

Group S (n=30)

Active Comparator group

Description:

Sumatriptan group

Treatment:

Drug: Sumatriptan Succinate Oral Tablet