Juvenile Idiopathic Arthrithis (JIA)
Conditions
Interventions
Product Name: Medimix
Product Code: NO
Pharmaceutical Form: Inhalation gas
Other descriptive name: nitrous oxide/oxygen
Concentration unit: % percent
Concentration type: equal
Sponsors
Queen Silvia's Childrens hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. ASA 1 and ASA 2 patients with an acute phase of of JIA 2. Age 5-18 years 3. Written informed consent by patient and/or parent. The doctor have initially asked and informed about participation in the study if there are no contra-indications Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. More than 3 joints need intra articular cortisone injection 2. Language difficulties 3. Present infection 4. Psychologically unstable patients (for example psychogical trauma, bad experience from war etc) 5. Clinically significant heart/lung disease 6. Pathological B12-status 7. Affected CNS 8. Porphyria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective To test the primary hypothesis: 1. PAIN: Patient will not grade his/her pain higher during joint injection (procedural pain), than before the procedure (base line of pain). This is measured by Coloured Analogue Scale (CAS) by the patient. 2. TOTAL IMPRESSION: Patient state that they prefer Nitrous Oxide (50%N2O/50%O2) during a future joint injection, to receive adequate analgesia and sedation. This is measured by asking the patient immediately after the procedure and after one week, endpoint yes – no. Each patient will also grade his/her feelings before, during and after procedure by Facial Analogue Scale (FAS) immediately after the procedure and after one week. ;Secondary Objective: To test secondary hypothesis: 1. TOTAL IMPRESSION: Nitrous Oxide (50%N2O/50%O2) is the method for receiving analgesia and sedation that the patient believes is the best during joint injections, according to those patients whom have tried other methods for receiving analgesia and sedation during joint injections. 2. FASTING TIME: No increase of presence of nausea and vomiting for those patients that have two hours fasting time versus those patients that have four hours of fasting time. Patients who are subject to a second treatment with joint injections during the course of the study will be asked to test Guided Imagery for analgesia. Nitrous Oxide (50%N2O/50%O2) is then told by the patient to be better than Guided Imagery regarding analgesia, when we ask the patient immediatly after procedure and after one week. ;Primary end point(s): Primary variables: 1. PAIN Patient will grade his/her pain before the procedure (baseline of pain) and during joint injection (preocedural pain), by Coloured Analogue Scale (CAS). Endpoints are from “no pain” – “worst pain ever experienced” 2. TOTAL IMPRESSION Patients will be asked immediately after the procedure, and after one week if they prefer Nitrous Oxide (50%N2O/50%O2) during a future joint injection | — |
Countries
Sweden
Outcome results
None listed