Is Theophylline More Effective Than Sumatriptan 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 oral theophylline versus oral sumatriptan 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 T, received oral theophylline, and group S, received oral sumatriptan.

Official Title
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Is Theophylline More Effective Than Sumatriptan 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: Theophylline Anhydrous Oral Tablet
* Drug: Sumatriptan Succinate Oral Tablet


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 History of peripheral vascular disease (ischemic colitis) Signs of meningismus Dysrhythmia Hypertension Ischemic heart disease Hyperthyroidism Liver or Renal impairment Use of selective serotonin reuptake inhibitors (SSRIs) Use of ergotamine derivatives in the past 24 hours Use of monoamine oxidase inhibitors (MAOIs) in the last two weeks Use of any kind of opiates Allergy to the study medications Any contraindication of oral intake

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 T (n=30)<br>Theophylline group | Drug: Theophylline Anhydrous Oral Tablet<br>* Theophylline tablet (150 mg/12h)<br>* Other names: Quibron-T/SR tablets;|
| Active Comparator: Group S (n=30)<br>Sumatriptan group | Drug: Sumatriptan Succinate Oral Tablet<br>* Sumatriptan tablet (25 mg/12h)<br>* Other names: Sumigran tablets;|

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 [(median (range)] | 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, 18h, 24h, then every 12h till 48h) | 48 hours after initiation of treatment | 
| Mean and Standard deviation of Numeric Pain Rating Scale (NPRS) score (mean±SD) | 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, 18h, 24h, 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 | 
| Mean and Standard deviation of Length of hospital stay (days) (mean±SD) | Time from hospital admission till discharge | 48 hours after initiation of treatment | 
| Number of participants and Rate of Treatment-related side effects | Number of participants and Rate of: Palpitation, Dizziness, Gastric irritation, Nausea/Vomiting, Diarrhea, Warm sensations in the body, Tingling sensation, and Tightness in the chest, throat, neck, or jaws. | 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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Post-dural puncture headache, Spinal anesthesia, Sumatriptan, Theophylline