NCT03997006

Brief Summary

Objectives: To compare the safety and efficacy of IV aminophylline versus IV neostigmine/atropine mixture 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 A, received IV aminophylline, and group NA, received IV neostigmine/atropine mixture.

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 Jan 2019

Shorter than P25 for phase_4

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

Study Start

First participant enrolled

January 1, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 25, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

1 year

First QC Date

June 20, 2019

Last Update Submit

February 4, 2020

Conditions

Post-Dural Puncture Headache

Keywords

AminophyllineAtropineNeostigminePost-dural puncture headacheSpinal anesthesia

Outcome Measures

Primary Outcomes (1)

  • Median and Range of Numeric Pain Rating Scale (NPRS) score

    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, then every 12h till 48h)

    48 hours after initiation of treatment

Secondary Outcomes (2)

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

    48 hours after initiation of treatment

  • Number of participants and Rate of Treatment-related complications

    48 hours after initiation of treatment

Study Arms (2)

Group A (n=30)

ACTIVE COMPARATOR

Aminophylline group

Drug: IV Aminophylline

Group NA (n=30)

ACTIVE COMPARATOR

Neostigmine/Atropine group

Drug: IV Neostigmine Methylsulfate + Atropine Sulphate

Interventions

IV AminophyllineDRUG

IV Aminophylline (100 mg/8h)

Also known as: Minophylline-N ampoule
Group A (n=30)
IV Neostigmine Methylsulfate + Atropine SulphateDRUG

IV Neostigmine/Atropine mixture (20 μg/kg Neostigmine + 10 μg/kg Atropine)/8h

Also known as: Neostigmine ampoule, Atropine ampoule
Group NA (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
  • Signs of meningismus
  • Bronchial asthma
  • Arrhythmia
  • Hypertension
  • Ischemic heart disease
  • Hyperthyroidism

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

AminophyllineNeostigmineAtropine

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

EthylenediaminesDiaminesPolyaminesAminesOrganic ChemicalsTheophyllineXanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical PreparationsPhenylammonium CompoundsQuaternary Ammonium CompoundsOnium CompoundsAtropine DerivativesTropanesAzabicyclo CompoundsAza CompoundsBelladonna AlkaloidsSolanaceous AlkaloidsAlkaloidsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

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

June 20, 2019

First Posted

June 25, 2019

Study Start

January 1, 2019

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

February 5, 2020

Record last verified: 2020-02

Locations

EG(1)