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Self-control Trial to Evaluate the Role of Aprepitant in the Prophylaxis of Post-lumbar-punture-headache (PLPH)

Self-control Trial to Evaluate the Role of Aprepitant in the Prophylaxis of Post-lumbar-punture-headache (PLPH)

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02347878
Enrollment
85
Registered
2015-01-27
Start date
2015-04-30
Completion date
2015-12-31
Last updated
2015-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia, Lymphoma

Keywords

leukemia, lymphoma, lumbar puncture, intrathecal treatment, post-lumbar puncture headache

Brief summary

Headache following a lumbar puncture (post-lumbar-puncture headache,PLPH)is a common and often debilitating syndrome, which was reported to occur in about 40% patients who received lumbar puncture. Now there lacks of effective approaches in the prophylaxis of PLPH, although some physicians consider bed rest for at least 6 hours to be a useful methods (Some recent meta-analysis found no benefit of bed rest for any hours in the prevention of PLPH). Studies have found that P substances and its receptor (Neurokinin-1 receptor, NK-1R)have played an important role in the pathogenesis of PLPH. Thus, we hypothesize that use of NK-1R inhibitor (aprepitant) 1 hour before lumbar puncture may decrease the incidence of PLPH and lower the severity of PLPH.

Detailed description

Headache following a lumbar puncture (post-lumbar-puncture headache,PLPH)is a common and often debilitating syndrome, which was reported to occur in about 40% patients who received lumbar puncture. Now there lacks of effective approaches in the prophylaxis of PLPH, although some physicians consider bed rest for at least 6 hours to be a useful methods (Some recent meta-analysis found no benefit of bed rest for any hours in the prevention of PLPH). Studies have found that P substances and its receptor (Neurokinin-1 receptor, NK-1R)have played an important role in the pathogenesis of PLPH. Thus, we hypothesize that use of NK-1R inhibitor (aprepitant) 1 hour before lumbar puncture may decrease the incidence of PLPH and lower the severity of PLPH.

Interventions

DRUGAprepitant

use aprepitant 1 hour before lumbar puncture and intrathecal treatment

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Patients diagnosed as acute leukemia, or lymphoma * Patients will received repeated lumbar puncture (at least 2 times, and at least 2 weeks apart) and intrathecal treatment * Without CNS involvement * Without headache for at least 1 week before the day of lumbar puncture * The platelet count was at least 30×10e9/L

Exclusion criteria

* With CNS involvement of disease * With headache before lumbar puncture * Needs lumbar puncture more than once a week

Design outcomes

Primary

MeasureTime frame
incidence of any grade post-lumbar-puncture headachedate from the day of lumbar puncture to 2 weeks after lumbar puncture

Secondary

MeasureTime frame
incidence of grade 3/4 post-lumbar-puncture headachedate from the day of lumbar puncture to 2 weeks after lumbar puncture

Countries

China

Contacts

Primary ContactLiang Wang, doctor
wangliang@sysucc.org.cn+86-20-87342462

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026