Lumbar Puncture
Conditions
Keywords
Lumbar puncture, Adults, Nitrous oxide, Procedural pain, Procedural anxiety
Brief summary
This study is designed to evaluate the analgesic effect of nitrous oxide (N2O) on the pain induced during lumbar puncture.
Detailed description
Nitrous oxide (N2O) has analgesic and anxiolytic properties that are known for more than a century. Nonetheless, it's use during lumbar puncture in adults has never been investigated properly. Thus, this study is designed to evaluate the analgesic effect of N2O on the pain induced during lumbar puncture. Patients with scheduled lumbar puncture realized for diagnosis purposes will be randomized in 2 groups. One group will inhale N2O for the 5 minutes before the puncture and during the rest of the procedure. The second group will inhale compressed air during the same period of time. Neither the investigator realizing the lumbar puncture, nor the patient will know which type of gaz they are inhaling (double-blinding). The maximal pain level that occurred during the procedure will be evaluated on a Numerical Rating Scale (NRS). NRS will also be used to evaluate the maximal anxiety induced by the procedure.
Interventions
DRUG50:50 mixture of nitrous oxide/oxygen
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients coming in the neurology department for a scheduled lumbar puncture * 18 to 60 years. * no previous use of nitrous oxide
Exclusion criteria
* contra-indication to nitrous oxide use * Body Mass Index\>35 * Mini Mental State Examination \<26/30 * Temperature \>38°C * Confusion * Patient unable to communicate verbaly
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximal pain level during the procedure | at day 1 |
Secondary
| Measure | Time frame |
|---|---|
| Maximal anxiety level during the procedure | at day 1 |
| Anxiety evaluated by 2 questionnaires: the Hospital Anxiety and Depression (HAD) State Trait Anxiety Inventory (STAI) | at day 1 |
| Proportion of patients presenting side effects | at day 1 |
| Total duration of the lumbar puncture | at day 1 |
| Proportion of patients that would accept another lumbar puncture in the same conditions | at day 1 |
Countries
France
Contacts
Primary ContactPatrick LACARIN
Outcome results
None listed