biostudies-literatureUnknown20(3)Cartron E<h4>Aim(s)</h4>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.<h4>Design</h4>A prospective, open-label, non-inferiority, multicenter trial including hospitalized patients requiring a diagnostic lumbar puncture in seven hospitals in France.<h4>Methods</h4>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.<h4>Results</h4>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%.<h4>Conclusion</h4>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.<h4>Impact</h4>The value of questioning the appropriateness of non-evidence-based nursing care may allow time to be devoted to more relational and comforting care.<h4>Reporting method</h4>The study adheres to the CONSORT reporting guidelines.<h4>Patient or public contribution</h4>No patient or public contribution.<h4>Trial registration</h4>Clinical Trials.gov (NCT02859233, August 9, 2016).PloS onee0319481https://www.ebi.ac.uk/biostudies/studies/S-EPMC11903041biostudies-literatureOral fluid supplementation for the prevention of post-dural puncture headache: A noninferiority randomized controlled trial.PMC11903041Queau MABoutoille DGazeau EBallet CCatinault MCharreau RVolteau CTalarmin JPCartron EVoisine ADauvergne JEHaubertin CLeroy MfalseOral fluid supplementation for the prevention of post-dural puncture headache: A noninferiority randomized controlled trial.<h4>Aim(s)</h4>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.<h4>Design</h4>A prospective, open-label, non-inferiority, multicenter trial including hospitalized patients requiring a diagnostic lumbar puncture in seven hospitals in France.<h4>Methods</h4>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.<h4>Results</h4>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%.<h4>Conclusion</h4>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.<h4>Impact</h4>The value of questioning the appropriateness of non-evidence-based nursing care may allow time to be devoted to more relational and comforting care.<h4>Reporting method</h4>The study adheres to the CONSORT reporting guidelines.<h4>Patient or public contribution</h4>No patient or public contribution.<h4>Trial registration</h4>Clinical Trials.gov (NCT02859233, August 9, 2016).2025-01-01T00:00:00Z20252026-06-01T05:39:23.577Z2025-04-04T09:06:45.92ZS-EPMC119030414007336610.1371/journal.pone.0319481