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

Primary Purpose

Post-Dural Puncture Headache

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
IV Aminophylline
IV Neostigmine Methylsulfate + Atropine Sulphate
Sponsored by
Damanhour Teaching Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Dural Puncture Headache focused on measuring Aminophylline, Atropine, Neostigmine, Post-dural puncture headache, Spinal anesthesia

Eligibility Criteria

21 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Damanhour Teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A (n=30)

Group NA (n=30)

Arm Description

Aminophylline group

Neostigmine/Atropine group

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Mean and Standard deviation of PDPH duration (hours) (mean±SD)
Time from PDPH onset till NPRS score ≤ 3
Number of participants and Rate of Treatment-related complications
Number of participants and Rate of: Diarrhea, Palpitation, Abdominal cramps, Muscle twitches, Bronchospasm, Urinary bladder hyperactivity

Full Information

First Posted
June 20, 2019
Last Updated
February 4, 2020
Sponsor
Damanhour Teaching Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03997006
Brief Title
Is Aminophylline More Effective Than Neostigmine/Atropine Mixture in the Treatment of Post-dural Puncture Headache
Acronym
RCT
Official Title
Is Aminophylline More Effective Than Neostigmine/Atropine Mixture in the Treatment of Post-dural Puncture Headache: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
January 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damanhour Teaching Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Dural Puncture Headache
Keywords
Aminophylline, Atropine, Neostigmine, Post-dural puncture headache, Spinal anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A (n=30)
Arm Type
Active Comparator
Arm Description
Aminophylline group
Arm Title
Group NA (n=30)
Arm Type
Active Comparator
Arm Description
Neostigmine/Atropine group
Intervention Type
Drug
Intervention Name(s)
IV Aminophylline
Other Intervention Name(s)
Minophylline-N ampoule
Intervention Description
IV Aminophylline (100 mg/8h)
Intervention Type
Drug
Intervention Name(s)
IV Neostigmine Methylsulfate + Atropine Sulphate
Other Intervention Name(s)
Neostigmine ampoule, Atropine ampoule
Intervention Description
IV Neostigmine/Atropine mixture (20 μg/kg Neostigmine + 10 μg/kg Atropine)/8h
Primary Outcome Measure Information:
Title
Median and Range of Numeric Pain Rating Scale (NPRS) score
Description
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)
Time Frame
48 hours after initiation of treatment
Secondary Outcome Measure Information:
Title
Mean and Standard deviation of PDPH duration (hours) (mean±SD)
Description
Time from PDPH onset till NPRS score ≤ 3
Time Frame
48 hours after initiation of treatment
Title
Number of participants and Rate of Treatment-related complications
Description
Number of participants and Rate of: Diarrhea, Palpitation, Abdominal cramps, Muscle twitches, Bronchospasm, Urinary bladder hyperactivity
Time Frame
48 hours after initiation of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed M Shaat, MD
Organizational Affiliation
Damanhour Teaching Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Damanhour Teaching Hospital
City
Damanhūr
State/Province
El-Beheira
Country
Egypt

12. IPD Sharing Statement

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

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