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

Phase 4

Completed

• Conditions: Post-Dural Puncture Headache
• Interventions: Drug: Theophylline Anhydrous Oral Tablet; Drug: Sumatriptan Succinate Oral Tablet

• Registration Number: NCT04257851
• Lead Sponsor: Damanhour Teaching Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-02
• Study First Submitted: 2020-02-04
• Study First Submitted QC: 2020-02-05
• Study First Posted: 2020-02-06
• Study Start: 2020-02-15
• Primary Completion: 2021-05-15
• Study Completion: 2021-05-15
• Last Update Submitted: 2021-05-31
• Last Update Posted: 2021-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group T (n=30)	Theophylline Anhydrous Oral Tablet	Theophylline group
Group S (n=30)	Sumatriptan Succinate Oral Tablet	Sumatriptan group

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Damanhour Teaching Hospital; 🇪🇬 Damanhūr, El-Beheira, Egypt