NCT04257851

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
9 days until next milestone

Study Start

First participant enrolled

February 15, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2021

Completed
Last Updated

June 3, 2021

Status Verified

February 1, 2020

Enrollment Period

1.2 years

First QC Date

February 4, 2020

Last Update Submit

May 31, 2021

Conditions

Post-Dural Puncture Headache

Keywords

Post-dural puncture headacheSpinal anesthesiaSumatriptanTheophylline

Outcome Measures

Primary Outcomes (2)

  • 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)

    48 hours after initiation of treatment

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

    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)

    48 hours after initiation of treatment

Secondary Outcomes (3)

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

    48 hours after initiation of treatment

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

    48 hours after initiation of treatment

  • Number of participants and Rate of Treatment-related side effects

    48 hours after initiation of treatment

Study Arms (2)

Group T (n=30)

ACTIVE COMPARATOR

Theophylline group

Drug: Theophylline Anhydrous Oral Tablet

Group S (n=30)

ACTIVE COMPARATOR

Sumatriptan group

Drug: Sumatriptan Succinate Oral Tablet

Interventions

Theophylline Anhydrous Oral TabletDRUG

Theophylline tablet (150 mg/12h)

Also known as: Quibron-T/SR tablets
Group T (n=30)
Sumatriptan Succinate Oral TabletDRUG

Sumatriptan tablet (25 mg/12h)

Also known as: Sumigran tablets
Group S (n=30)

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with NPRS score of ≥ 5
  • American Society of Anesthesiologists (ASA) physical status ≤ II
  • Age from 21 to 50 years

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damanhour Teaching Hospital

Damanhūr, El-Beheira, Egypt

Location

MeSH Terms

Conditions

Post-Dural Puncture Headache

Interventions

TheophyllineSumatriptan

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingSulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsTryptaminesIndoles

Study Officials

  • Ahmed M Shaat, MD

    Damanhour Teaching Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2020

First Posted

February 6, 2020

Study Start

February 15, 2020

Primary Completion

May 15, 2021

Study Completion

May 15, 2021

Last Updated

June 3, 2021

Record last verified: 2020-02

Locations

EG(1)