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

Sponsor
Damanhour Teaching Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04257851
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
14.9
Actual Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Theophylline Anhydrous Oral Tablet
  • Drug: Sumatriptan Succinate Oral Tablet
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Is Theophylline More Effective Than Sumatriptan in the Treatment of Post-dural Puncture Headache: A Randomized Clinical Trial
Actual Study Start Date :
Feb 15, 2020
Actual Primary Completion Date :
May 15, 2021
Actual Study Completion Date :
May 15, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group T (n=30)

Theophylline group

Drug: Theophylline Anhydrous Oral Tablet
Theophylline tablet (150 mg/12h)
Other Names:
  • Quibron-T/SR tablets

    		•
    Active Comparator: Group S (n=30)

    Sumatriptan group

    Drug: Sumatriptan Succinate Oral Tablet
    Sumatriptan tablet (25 mg/12h)
    Other Names:
  • Sumigran tablets

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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)

    2. 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

    1. Mean and Standard deviation of PDPH duration (hours) (mean±SD) [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) [48 hours after initiation of treatment]

      Time from hospital admission till discharge

    3. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Damanhour Teaching Hospital Damanhūr El-Beheira Egypt

    Sponsors and Collaborators

    • Damanhour Teaching Hospital

    Investigators

    • Principal Investigator: Ahmed M Shaat, MD, Damanhour Teaching Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Damanhour Teaching Hospital
    ClinicalTrials.gov Identifier:
    NCT04257851
    Other Study ID Numbers:
    • DTH: 20001
    First Posted:
    Feb 6, 2020
    Last Update Posted:
    Jun 3, 2021
    Last Verified:
    Feb 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Damanhour Teaching Hospital
    Post-dural puncture headache
    Spinal anesthesia
    Sumatriptan
    Theophylline
    Additional relevant MeSH terms:
    Post-Dural Puncture Headache
    Headache
    Wounds and Injuries
    Sumatriptan
    Theophylline

    Study Results

    No Results Posted as of Jun 3, 2021