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Theophylline, Versus Sumatriptan and Gabapentin in The Treatment of Post-Dural Puncture Headache

ConditionsTheophyllineSumatriptanGabapentinPost-Dural Puncture Headache
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-50
SponsorTanta University

About this trial

The aim of this study is to compare the safety and efficacy of theophylline, sumatriptan, and gabapentin in the treatment of post-dural puncture headache.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age from 21 to 50 years.

Both sexes.

American Society of Anesthesiologists (ASA) physical status ≤ II.

Patient's selection for this study will be based on clinical diagnosis suggesting post-dural puncture headache (PDPH) based on the International Headache Society criteria.

Disqualifiers

Pregnant women.

History of; chronic headache, cluster headache, migraine, convulsions, cerebrovascular accident, and previous neurological diseases.

Signs of meningismus.

Dysrhythmia.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Theophylline

    Drug

    Patients included in this group will receive oral 150 mg theophylline anhydrous tablet (QuibronT/SR, 300 mg dividose tablet, SmithKline Beecham Egypt L.L.C) every 12 hours.

  • Sumatriptan

    Drug

    Patients included in this group will receive oral 25 mg sumatriptan succinate tablet (Sumigran 25, 25 mg tablet, Sigma pharmaceutical industries, Egypt) every 12 hours.

  • Gabapentin

    Drug

    Patients included in this group will receive 200 mg of gabapentin every 12 hours.

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: Group TExperimental treatment 1 intervention
Group B: Group SExperimental treatment 1 intervention
Group C: Group GExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Severity of headache

Severity of headache will be assessed using numeric rating scale (NRS) score where 0 = no pain, and 10 = worst possible pain.

Time frame
24 hours after drug treatment.

Secondary outcomes

1

Post-Dural Puncture Headache duration

Post-Dural Puncture Headache (PDPH) duration will be recorded from the occurrence of PDPH till numeric rating scale (NRS) score ≤3.

Time frame
24 hours after drug treatment.
2

Length of hospital stay

Length of hospital stay will be recorded from the hospital admission till discharge.

Time frame
Till the discharge from the hospital (Up to 2 weeks)
3

Treatment-related side effects

Treatment-related side effects such as palpitation, dizziness, gastric irritation, nausea/vomiting, diarrhea, warm sensations in the body, tingling sensation, and tightness in the chest, throat, neck, or jaws will be recorded.

Time frame
24 hours after drug treatment.
4

Total amount of rescue analgesia consumption

Total amount of rescue analgesia consumption will be measured.

Time frame
24 hours after drug treatment.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tanta University

Lead sponsor

Source ClinicalTrials.gov
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