drugset / Trial / NCT03997006

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

NCT03997006

Phase 4 Completed 60 enrolled Damanhour Teaching Hospital
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2019-01-01
Primary completion
2020-01-01
Completion
2020-01-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aminophylline Small molecule 100 mg Intravenous
Comparator Atropine Other / unclassified 10 ug/kg Intravenous
Comparator Neostigmine Methylsulfate Small molecule 20 ug/kg Intravenous