Is Theophylline More Effective Than Sumatriptan in the Treatment of Post-dural Puncture Headache

Is Theophylline More Effective Than Sumatriptan in the Treatment of Post-dural Puncture Headache: A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Post-Dural Puncture Headache
• Intervention / Treatment: Drug: Theophylline Anhydrous Oral Tablet; Drug: Sumatriptan Succinate Oral Tablet

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

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
• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group T (n=30); Theophylline group	Drug: Theophylline Anhydrous Oral Tablet; Theophylline tablet (150 mg/12h); Other Names: Quibron-T/SR tablets
Active Comparator: Group S (n=30); Sumatriptan group	Drug: Sumatriptan Succinate Oral Tablet; Sumatriptan tablet (25 mg/12h); Other Names: Sumigran tablets

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Damanhour Teaching Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2020
• Primary Completion (Actual): May 15, 2021
• Study Completion (Actual): May 15, 2021

Study Registration Dates

• First Submitted: February 4, 2020
• First Submitted That Met QC Criteria: February 5, 2020
• First Posted (Actual): February 6, 2020

Study Record Updates

• Last Update Posted (Actual): June 3, 2021
• Last Update Submitted That Met QC Criteria: May 31, 2021
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Spinal anesthesia; Sumatriptan; Post-dural puncture headache; Theophylline
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders; Headache Disorders, Secondary; Wounds and Injuries; Headache; Post-Dural Puncture Headache; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Purinergic Antagonists; Purinergic Agents; Serotonin Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Vasoconstrictor Agents; Theophylline; Sumatriptan
• Other Study ID Numbers: DTH: 20001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No