Oral fluid supplementation for the prevention of post-dural puncture headache: A noninferiority randomized controlled trial.

Abstract

Aim(s): To investigate the impact of the absence of specific advice for oral fluid intake, compared to supplementation water intake on the occurrence of post-dural puncture headache.

Design: A prospective, open-label, non-inferiority, multicenter trial including hospitalized patients requiring a diagnostic lumbar puncture in seven hospitals in France.

Methods: Patients were randomly allocated (1:1) either to receive no specific advice on oral fluid intake (FREE-FLUID), or to be encouraged to drink 2 liters of water (CONTROL) within the 2 hours after lumbar puncture. The primary outcome was the post-dural puncture headache rate within the 5 days after lumbar puncture, with a non-inferiority margin of 10%. The secondary outcome was the time-to-post-dural puncture headache onset between Day 0 and Day 5.

Results: From November 2016 and July 2019, we have included 554 participants. The primary outcomes occurs in 33.1% patients in the FREE-FLUID group, versus 38.0% in the CONTROL group with adjusted difference of 3.7%.

Conclusion: Among patients who had lumbar puncture, our study shows the noninferiority of the absence of specific advice on water intake after a lumbar puncture, compared with advice to increase oral fluid to prevent a post-dural puncture headache.

Impact: The value of questioning the appropriateness of non-evidence-based nursing care may allow time to be devoted to more relational and comforting care.

Reporting method: The study adheres to the CONSORT reporting guidelines.

Patient or public contribution: No patient or public contribution.

Trial registration: Clinical Trials.gov (NCT02859233, August 9, 2016).