Anxiety, Pain
Conditions
Keywords
Spinal puncture, Nitrous oxide, Pain, Anxiety, Emergency
Brief summary
Lumbar puncture (LP) is a frequent exam that can cause pain and anxiety. In a scheduled setting, it has been shown that nitrous oxide use during the procedure was able to reduce both pain and anxiety. The goal of this trial is to confirm these results in a more heterogeneous group of patients having a LP, in an emergency setting.
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 only been investigated in a scheduled setting.Thus, this study is designed to evaluate the analgesic effect of N2O on the pain induced during lumbar puncture. Patients with urgent 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. 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
Gaz inhalation will start 5 minutes before the puncture and will be continued until the end of the procedure.
OTHERPlacebo
inhale medical air (22% O2 - 78% N2)
Sponsors
Institut National de la Santé Et de la Recherche Médicale, France
Université d'Auvergne
University Hospital, Clermont-Ferrand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
double blinding, gas bottles are in undistinguishable boxes, and each gas mask will be filled with odorous ink masking the sweet flavour of N2O. Neither the patient nor the person doing the LP and/or the evaluation of pain and anxiety will know the treatment used
Intervention model description
1:1 randomization to receive experimental treatment (50% N2O - 50% O2) or placebo (Medical Air: 22% O2 - 78% N2).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients coming in emergency service who need a lumbar puncture in emergency for a diagnostic purpose * at least 18 * affiliated to the French state healthcare insurance system * able to give consent to participation
Exclusion criteria
* Previous use of nitrous oxide (medical or recreational) * Contra-indication to nitrous oxide use * Face mask phobia * Stage II obesity (BMI \> 35) * Hemodynamic instability and/or any case when coagulation results cannot be waited * Cognitive condition defined by a previous Mini Mental State Examination \< 24/30 * Confusion or any consciousness disorder that might interfere with judgment or consent * Patient unable to communicate verbally * Patient placed under a legal protection measure (tutorship, curatorship or a mandate) * Any medical condition that might contra-indicate medical research, in physician's opinion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximal pain perceived during the lumbar puncture evaluated using a simple numeric 0-10 pain scale | 2-3 minutes after the end of gas inhalation | Maximal level of pain during lumbar puncture. The patient will be asked to circle the digit that best describes the maximal level of pain felt during the procedure. If the patient is too painful and/or is incapacitated, the collection notebook will be fulfilled by the care provider after asking the following question: On a scale of 0 to 10, 0 being the absence of pain and 10 the maximal pain you can imagine, what is the digit best describing the maximal pain you felt during the procedure? |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side effects | From the beginning of gas inhalation to a minimum of 2 hours later | Every side effect reported by the patients attributable to gas inhalation during the procedure up to emergency service discharge. Presence, intensity and reversibility will be recorded |
| Spinal puncture duration | 2-3 minutes after the end of lumbar puncture | Comparison of LP duration between both groups measured in minutes (from the beginning of gas inhalation to needle removal). |
| Number of attempts before successful LP | 2-3 minutes after the end of lumbar puncture | Comparison of number of attempts needed to get spinal fluid, defined as number of needle removals for a single exam. |
| Maximal anxiety perceived during lumbar puncture evaluated using a simple numeric 0-10 scale | 2-3 minutes after the end of gas inhalation | Proportion of patients with significant anxiety |
| Blinding quality | 2-3 minutes after the end of gas inhalation | Assessment of blinding in clinical trials (according to Bang et al. 2004) |
| Induced cost | through study completion, an average 4 months | supplementary cost induced by the use of nitrous oxide inhalation for a total of 88 patients throughout the study (gas and consumables such as masks and pipes) |
| Patient Satisfaction | 2-3 minutes after the end of gas inhalation | overall satisfaction based on a 0-10 score and proportion of patients that would accept another lumbar puncture in the same conditions |
Countries
France
Contacts
Primary ContactLise LACLAUTRE, Dr
Outcome results
None listed