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

TL;DR

This study found that not giving specific advice about drinking water after a lumbar puncture is just as effective as advising patients to drink 2 liters of water in preventing headaches.

Contribution

The study provides evidence that fluid supplementation advice after lumbar puncture is not necessary for preventing post-dural puncture headaches.

Findings

FREE-FLUID group had a 33.1% headache rate versus 38.0% in the CONTROL group.

The adjusted difference of 3.7% supports noninferiority within the 10% margin.

Questioning non-evidence-based nursing practices may improve patient care efficiency.

Abstract

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.

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

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.

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%.

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.

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

The study adheres to the CONSORT reporting guidelines.

No patient or public contribution.

Clinical Trials.gov (NCT02859233, August 9, 2016).

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