Numeric Pain Rating Scale > 5 / 10, Severe Traumatic Pain
Conditions
Keywords
Acute Pain, Traumatic Pain, Emergency setting, Prehospital setting, Analgesia, Intranasal device, Intra veinous injection, Sufentanil citrate, Morphine Sulfate
Brief summary
Intranasal (IN) administration of opiates is an appealing non-invasive way of treating acute traumatic pain in prehospital and Emergency departments (ED). The investigators hypothesize that IN administration of Sufentanil is equal as compared with Intra veinous (IV) administration of Morphine wich is widely recommended in ED. The investigators study is a multicentric, comparative, randomized, double-blind, double-placebo study, comparing quality of analgesia in both groups 30 minutes after first administration of opiates. The investigators also asses side effects and patient satisfaction in both groups.
Interventions
DRUGMorphine
Intravenous administration Patient receives simultaneously IV morphine administration and IN placebo spray. Pain is controlled by: * at 0 minute : Placebo IN (2 sprays, one spray in each nostril) + morphine IV 0,1mg/kg * at 10 minutes and if NPRS\>3 : Placebo IN (1 spray) + morphine IV 0,05mg/kg * at 20 minutes and if NPRS\>3: Pacebo (1 spray) + morphine IV 0,05mg/kg
DRUGSufentanil
Intranasal spray with one spray, equivalent to an half-dose. Patient receives simultaneously IV placebo administration and IN sufentanil spray. Pain is controlled by: * at 0 minute : Sufentanil IN 0,3µg/kg (2 sprays, one spray in each nostril) + NaCl 0,9% IV * at 10 minutes and if NPRS\>3 : Sufentanil IN 0,15µg/kg (1 spray) + NaCl 0,9% IV * at 20 minutes and if NPRS\>3: Sufentanil IN 0,15µg/kg (1 spray) + NaCl 0,9% IV
DRUGPlacebo
Intravenous administration Patient receives simultaneously IV placebo administration and IN sufentanil spray. Pain is controlled by: * at 0 minute : Sufentanil IN 0,3µg/kg (2 sprays, one spray in each nostril) + NaCl 0,9% IV * at 10 minutes and if NPRS\>3 : Sufentanil IN 0,15µg/kg (1 spray) + NaCl 0,9% IV * at 20 minutes and if NPRS\>3: Sufentanil IN 0,15µg/kg (1 spray) + NaCl 0,9% IV
Sponsors
Fondation Apicil
SFMU
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Traumatic pain * Numeric Pain Rating Scale (NPRS) \>5 /10 * Age between 18 and 75 years old
Exclusion criteria
* Medical pain (headache, chest pain,...) * Respiratory, renal or hepatic insufficiency * Drug addiction * Medical or Chirurgical sinus history * Oxygene saturation \< 90% * Systolic blood pressure \< 90mmHg * Head injury with a neurological Glasgow Coma Scale (GCS) \< 14 * Opioid allergy * Facial traumatism * Patient unable do understand or assessing NPRS * Opiates administration within 6 hours before admission
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficiency of Analgesia | 30 minutes | Patient self-assessed pain intensity using Numeric Pain Rating Scale (0 to 10). 30 minutes after the first opiate administration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid-related side effects | 10 minutes | Sedation Score, Breathing Rate, Oxygen Saturation, Arterial Blood Pressure, Heart rate, Nasal Ulceration. Proportion of patients having opioid-related side effects. |
| Efficiency of Analgesia | Every 10 minutes | Patient self-assessed pain intensity using Numeric Pain Rating Scale (0 to 10). 10 minutes and 20 minutes after the first opiate administration. |
| Patient Satisfaction | 40 min | — |
| Specific Analysis for the pre hospital setting group: Efficiency of Analgesia | Every 10 minutes | Patient self-assessed pain intensity, using Numeric Pain Rating Scale (0 to 10) at 10, 20 and 30 min after the first opiate administration |
Countries
France
Outcome results
None listed