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NCT Number: NCT04257851

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

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.

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Key information

Conditions

Post-Dural Puncture Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Secondary Nervous System Diseases

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Damanhour Teaching Hospital

Damanhūr, El-Beheira, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Theophylline Anhydrous Oral Tablet

Drug

Theophylline tablet (150 mg/12h)

Other names: Quibron-T/SR tablets

Sumatriptan Succinate Oral Tablet

Drug

Sumatriptan tablet (25 mg/12h)

Other names: Sumigran tablets

Primary outcomes

  1. Median and Range of Numeric Pain Rating Scale (NPRS) score [(median (range)]

    Time frame: 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)

  2. Mean and Standard deviation of Numeric Pain Rating Scale (NPRS) score (mean±SD)

    Time frame: 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 outcomes

  1. Mean and Standard deviation of PDPH duration (hours) (mean±SD)

    Time frame: 48 hours after initiation of treatment

    Time from PDPH onset till NPRS score ≤ 3

  2. Mean and Standard deviation of Length of hospital stay (days) (mean±SD)

    Time frame: 48 hours after initiation of treatment

    Time from hospital admission till discharge

  3. Number of participants and Rate of Treatment-related side effects

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Damanhour Teaching Hospital

Other Gov

Registry information

Official study title

Is Theophylline More Effective Than Sumatriptan in the Treatment of Post-dural Puncture Headache: A Randomized Clinical Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 6, 2020
Registry last updated
Jun 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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