RecruitingPhase 2NCT05116930

Neostigmine and Glycopyrrolate for the Treatment of Headache After Dural Puncture

Neostigmine and Glycopyrrolate for the Treatment of Post Dural Puncture Headache After Known Dural Puncture With a Tuohy Needle: A Pilot Study


Sponsor

Mayo Clinic

Enrollment

18 participants

Start Date

Nov 19, 2021

Study Type

INTERVENTIONAL

Summary

The purpose of this study is to evaluate Neostigmine and Glycopyrrolate to treat post-dural puncture headache (PDPH) to reduce the proportion of postpartum women with a PDPH requiring epidural blood patch (EBP) who developed a PDPH after accidental dural puncture.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 54 Years

Inclusion Criteria2

  • Post-dural puncture headache (PDPH) after documented dural puncture with Tuohy needle during placement of epidural analgesia for labor and no other explanation for headache (HA).
  • Onset of HA within 72 hours of delivery.

Exclusion Criteria12

  • Patient refusal.
  • Visual analog scale (NRS) score < 4.
  • History of migraine headaches.
  • Asthma.
  • Arrhythmia.
  • Heart block.
  • Myasthenia gravis.
  • Inability to understand pain scores and other questionnaires.
  • Inability to speak English.
  • Contraindication to acetaminophen or NSAIDs.
  • Temperature > 38.5 C.
  • Prior EBP done for this HA.

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Interventions

DRUGNeostigmine

IV infusion 20 μg/kg over 10 minutes repeated every 8 hours for a maximum of 3 doses

DRUGGlycopyrrolate

IV infusion 4 μg/kg over 10 minutes repeated every 8 hours for a maximum of 3 doses


Locations(1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

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NCT05116930