Multiple Trauma, Pain, Acute
Conditions
Brief summary
Abstract Background: Given the inadequate control of pain in patients with injury that refer to the emergency departments, the rapid onset of action of intranasal administration in pain management, and the avoidance of administering opioid medications, the present study aimed at evaluating the effect of intranasal ketamine versus intranasal fentanyl on pain management in isolated traumatic patients Materials and Methods: The current study was performed on 125 patients that were divided into the following three groups: control group (n = 41), 1 mg/kg intranasal ketamine group (n = 40), and 1μg/kg intranasal fentanyl group (n = 44). Then pain scores, HR, RR, BP, and SaO2 were recorded at baseline, 5, 10, 15, 30, and 40 minutes after the intervention.
Interventions
DRUGPlacebo
Distilled water
DRUGKetamine
1 mg/kg intranasal ketamine
DRUGFentanyl
1μg/kg intranasal fentanyl
Sponsors
Isfahan University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
15 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* patients with acute limb trauma, aged 15-65 years, with moderate to severe pain (45 mm; visual analog scale (VAS)), with a GCS score of 15, with the systolic blood pressure of lower than 180 mmHg, diastolic blood pressure of higher than 90 mmHg * lack of pregnancy * no history of allergy to ketamine, fentanyl (or opioids), or acetaminophen, * no history of liver diseases, * no acute or chronic structural or functional nasal obstruction diseases, * no history of drug or psychiatric addiction, * no pain medication within the past four hours, * no history of heart disease, * and the presentation of the written consent to participate in the study.
Exclusion criteria
* a decrease in GCS score to less than or equal to 14, * an elevated systolic blood pressure to higher than 180 mmHg, * a decreased diastolic blood pressure to less than 80 mmHg, * inability to understand the VAS pain rating system, * symptoms of acute heart disease and respiratory depression (respiratory rate \<8 / min), * and the patient's dissatisfaction to continue the cooperation in study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual analogue score | Change from baseline at 40 minutes | a scale for measuring the extent of pain relief |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate (HR) | Change from baseline at 40 minutes | — |
| Blood pressure (BP) | Change from baseline at 40 minutes | — |
| Respiratory rate (RR) | Change from baseline at 40 minutes | — |
| SPO2 | Change from baseline at 40 minutes | Blood oxygen saturation |
Countries
Iran
Outcome results
None listed