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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03997006
Recruitment Status : Completed
First Posted : June 25, 2019
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Damanhour Teaching Hospital

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.


Condition or disease Intervention/treatment Phase
Post-Dural Puncture Headache Drug: IV Aminophylline Drug: IV Neostigmine Methylsulfate + Atropine Sulphate Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Is Aminophylline More Effective Than Neostigmine/Atropine Mixture in the Treatment of Post-dural Puncture Headache: A Randomized Clinical Trial
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : January 1, 2020
Actual Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
Active Comparator: Group A (n=30)
Aminophylline group
Drug: IV Aminophylline
IV Aminophylline (100 mg/8h)
Other Name: 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 Name: Neostigmine ampoule, Atropine ampoule




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03997006


Locations
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Egypt
Damanhour Teaching Hospital
Damanhūr, El-Beheira, Egypt
Sponsors and Collaborators
Damanhour Teaching Hospital
Investigators
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Principal Investigator: Ahmed M Shaat, MD Damanhour Teaching Hospital
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Responsible Party: Damanhour Teaching Hospital
ClinicalTrials.gov Identifier: NCT03997006    
Other Study ID Numbers: DTH:19001
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Damanhour Teaching Hospital:
Aminophylline
Atropine
Neostigmine
Post-dural puncture headache
Spinal anesthesia
Additional relevant MeSH terms:
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Post-Dural Puncture Headache
Headache
Wounds and Injuries
Pain
Neurologic Manifestations
Signs and Symptoms
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Atropine
Aminophylline
Acefyllin piperazinate
Neostigmine
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action