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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001452-28 |
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This study is designed to evaluate the analgesic effect of nitrous oxide (N2O) on the pain induced during lumbar puncture.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N20 | Experimental | One group will inhale N2O for the 5 minutes before the puncture and during the rest of the procedure. |
|
| compressed air | Other | The second group will inhale compressed air during the same period of time |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 50:50 mixture of nitrous oxide/oxygen | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximal pain level during the procedure | at day 1 |
| Measure | Description | 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick LACARIN | Contact | 04 73 75 11 95 | placarin@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| Pierre CLAVELOU | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Clermont-Ferrand | Recruiting | Clermont-Ferrand | 63003 | France |
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| 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 |
| ID | Term |
|---|---|
| D000073818 | Pain, Procedural |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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