Health TrialsbyHealthPanel

Neostigmine and Glycopyrrolate for the Treatment of Headache After Dural Puncture

ConditionPost-Dural Puncture Headache
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-54
SponsorMayo Clinic

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patient refusal.

Visual analog scale (NRS) score < 4.

History of migraine headaches.

Asthma.

Trial design

Design model

Single group

Treatments tested in this trial

  • Neostigmine

    Drug

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

  • Glycopyrrolate

    Drug

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

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: Postpartum dural puncture headache following dural puncture from Tuohy needleExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of postpartum women requiring epidural blood patch

Total number of postpartum women with a post dural puncture headache (PDPH) requiring epidural blood patch (EBP)

Time frame
2 weeks

Secondary outcomes

1

Change in pain scores

Measured using the Numeric Rating Scale (NRS) pain score (0-10) with patient in sitting position for 5 min

Time frame
Baseline, 1 hour, 8 hours, 16 hours, 24 hours, 48 hours, 1 week, and 2 weeks after intervention
2

Adverse Events

Total number of adverse events experienced by subjects

Time frame
2 weeks

Other outcomes

Sponsors and contacts

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

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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