Pregabalin for dural puncture headache

Phase 4

• Conditions: headache; Anaesthesiology - Pain management

• Registration Number: ACTRN12616000016437
• Lead Sponsor: King Edward Memorial Hospital for Women

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

1.Obstetric women aged 18 years and over
2.An unintentional dural puncture at the time of epidural analgesia for labour and delivery, confirmed by observation of efflux of cerebrospinal fluid from the needle or catheter; by identification of CSF from an epidural catheter; or by positive test-dosing for subarachnoid placement.

Exclusion Criteria

1.Attempted postpartum prevention of PDPH using any therapy other than intrathecal epidural catheter placement, including prophylactic epidural blood patch.
2.Onset of PDPH prior to study drug administration
3.Renal impairment
4.Contraindication to use or exposure to pregabalin within past 72 hours
5.ASA 4 status
6.Women planning to breastfeed a premature baby
7.Concurrent administration of drugs that may possibly impact on the severity of PDPH, namely oral tablets of or intravenous caffeine, triptans, hydrocortisone, oral theophylline or intravenous aminophylline, epidural morphine.

Study & Design

• Study Type: Interventional
• Study Design: Not specified