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

Study Overview
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Brief Summary
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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.

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

Conditions
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Post-Dural Puncture Headache

Intervention / Treatment
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* Drug: IV Aminophylline
* Drug: IV Neostigmine Methylsulfate + Atropine Sulphate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean and Standard deviation of PDPH duration (hours) (mean±SD) | Time from PDPH onset till NPRS score ≤ 3 | 48 hours after initiation of treatment | 
| 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 | 48 hours after initiation of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aminophylline, Atropine, Neostigmine, Post-dural puncture headache, Spinal anesthesia