Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2025 Mar 12;20(3):e0319481.
doi: 10.1371/journal.pone.0319481. eCollection 2025.

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

Emmanuelle Cartron  1   2 , Christelle Volteau  3 , Maxime Leroy  4 , Annastasia Voisine  3 , Jérôme Emmanuel Dauvergne  5 , Céline Ballet  6 , Jean-Philippe Talarmin  7 , Marie-Annick Quéau  7 , Marylène Catinault  8 , Emmanuelle Gazeau  9 , Carole Haubertin  10 , Romain Charreau  11 , David Boutoille  12
Affiliations
Randomized Controlled Trial

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

Emmanuelle Cartron et al. PLoS One. .

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).

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig 1
Fig 1. Flowchart Diagram of Participants in the study.
Legend: Boxplots indicate the median value (thick line inside the box), and the first and third quartile (thick line around the box). The circles represent outliers’ data. LP: lumbar puncture.
Fig 2
Fig 2. Volume of oral fluid intake within the 2 hours after LUMBAR PUNCTURE with respect of randomization group.
Fig 3
Fig 3. Difference of Post-dural Puncture Headache between FREE-FLUID group and CONTROL group.
Legend: Sensibility analysis 3 on ITT population ITT and risk factors adjustment ∆ indicates the non-inferiority margin of 10% Primary analysis with ITT population and missing data imputed as absence of Post-dural Puncture Headache Sensibility analysis 1 on PP population Sensibility analysis 2 on ITT population and multiple imputation on missing data.
See this image and copyright information in PMC

References

    1. Headache Classification Committee of the International Headache Society (IHS) . The international classification of headache disorders , 3rd edition. Cephalalgia. 2018;38(1):1–211. doi: 10.1177/0333102417738202 - DOI - PubMed
    1. Ahmed SV, Jayawarna C, Jude E. Post lumbar puncture headache: diagnosis and management. Postgrad Med J. 2006;82(973):713–6. doi: 10.1136/pgmj.2006.044792 - DOI - PMC - PubMed
    1. Bezov D, Lipton RB, Ashina S. Post-dural puncture headache: part I diagnosis, epidemiology, etiology, and pathophysiology. Headache. 2010;50(7):1144–52. doi: 10.1111/j.1526-4610.2010.01699.x - DOI - PubMed
    1. Amorim JA, Gomes de Barros MV, Valença MM. Post-dural (post-lumbar) puncture headache: risk factors and clinical features. Cephalalgia. 2012;32(12):916–23. doi: 10.1177/0333102412453951 - DOI - PubMed
    1. Arevalo-Rodriguez I, Ciapponi A, Roqué i Figuls M, Muñoz L, Bonfill Cosp X. Posture and fluids for preventing post-dural puncture headache. Cochrane Database Syst Rev. 2016;3(3):CD009199. doi: 10.1002/14651858.CD009199.pub3 - DOI - PMC - PubMed

Publication types

Associated data

LinkOut - more resources