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Role of Prophylaxis by Oral Fluid Supplementation in Prevention of Postdural Puncture Headache — PROPHYDRA  

Postdural Puncture Headache Clinical Trial

Official title:
Role of Prophylaxis by Oral Fluid Supplementation in Prevention of Postdural Puncture Headache: A Non-inferiority Randomized Controlled Trial

Clinical Trial Summary

Postdural puncture headache (PDPH) is defined, according to the International Headache Society, as any headache develops within 5 days after a lumbar puncture. It worsens within 15 minutes after sitting or standing and improves within 15 minutes after lying.

For preventing PDPH, there are some uncomfortable practices for patients (fluid supplementation and bed rest) and expensive for hospital (time spend for information and management of fluid intake). Patients are usually advised by nurses. If "bed rest" is not effective in prevention of PDPH, "fluid supplementation" is not an advice based on any evidence but only on routine. By this trial, the investigators want to evaluate the scientific value of this advice, in the standard patient care.

The primary objective of this study is to compare oral hyperhydration (2 liters during 2 hours after lumbar puncture - the most common routine according to an internal pilot survey) versus no advice about the fluid intake to prevent the PDPH.

The second objective is to observe the day of apparition of PDPH, between day 0 and day 5.

Clinical Trial Description

Postdural puncture headache (PDPH) is defined, according to the International Headache Society, as any headache develops within 5 days after a lumbar puncture. It worsens within 15 minutes after sitting or standing and improves within 15 minutes after lying.

For preventing PDPH, there are some uncomfortable practices for patients (fluid supplementation and bed rest) and expensive for hospital (time spend for information and management of fluid intake). Patients are usually advised by nurses. If "bed rest" is not effective in prevention of PDPH, "fluid supplementation" is not an advice based on any evidence but only on routine. By this trial, the investigators want to evaluate the scientific value of this advice by non-inferiority study, in the standard patient care.

The primary objective of this study is to compare oral hyperhydration (2 liters during 2 hours after lumbar puncture - the most common routine according to an internal pilot survey) versus no advice about the fluid intake to prevent the PDPH. It will be evaluated on the occurrence of PDPH in both of the two groups The second objective is to observe the day of apparition of PDPH, between day 0 and day 5. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02859233
Study type Interventional
Source Nantes University Hospital
Contact
Status Completed
Phase N/A
Start date November 8, 2016
Completion date July 23, 2019
View Details
See also
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