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

February 4, 2020 updated by: Damanhour Teaching Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • El-Beheira
      • Damanhūr, El-Beheira, Egypt
        • Damanhour Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A (n=30)
Aminophylline group
Drug: IV Aminophylline
IV Aminophylline (100 mg/8h)
Other Names:
  • Minophylline-N ampoule
Active Comparator: Group NA (n=30)
Neostigmine/Atropine group
Drug: IV Neostigmine Methylsulfate + Atropine Sulphate
IV Neostigmine/Atropine mixture (20 μg/kg Neostigmine + 10 μg/kg Atropine)/8h
Other Names:
  • Neostigmine ampoule, Atropine ampoule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
48 hours after initiation of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
48 hours after initiation of treatment
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
48 hours after initiation of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damanhour Teaching Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

June 20, 2019

First Submitted That Met QC Criteria

June 24, 2019

First Posted (Actual)

June 25, 2019

Study Record Updates

Last Update Posted (Actual)

February 5, 2020

Last Update Submitted That Met QC Criteria

February 4, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DTH:19001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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