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NCT Number: NCT03997006

Is Aminophylline More Effective Than Neostigmine/Atropine Mixture in the Treatment of Post-dural Puncture Headache

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.

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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
  • Signs of meningismus
  • Bronchial asthma
  • Arrhythmia
  • Hypertension
  • Ischemic heart disease
  • Hyperthyroidism

Treatment and study plan

IV Aminophylline

Drug

IV Aminophylline (100 mg/8h)

Other names: Minophylline-N ampoule

IV Neostigmine Methylsulfate + Atropine Sulphate

Drug

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

Other names: Neostigmine ampoule, Atropine ampoule

Primary outcomes

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

    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, 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. Number of participants and Rate of Treatment-related complications

    Time frame: 48 hours after initiation of treatment

    Number of participants and Rate of: Diarrhea, Palpitation, Abdominal cramps, Muscle twitches, Bronchospasm, Urinary bladder hyperactivity

Sponsors and collaborators

Lead sponsor

Damanhour Teaching Hospital

Other Gov

Registry information

Official study title

Is Aminophylline More Effective Than Neostigmine/Atropine Mixture in the Treatment of Post-dural Puncture Headache: A Randomized Clinical Trial

Acronym: RCT

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 25, 2019
Registry last updated
Feb 5, 2020

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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