Intranasal Ketamine Versus Intranasal Fentanyl

Study Overview
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Brief Summary
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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.

Official Title
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Intranasal Ketamine Versus Intranasal Fentanyl on Pain Management in Isolated Traumatic Patients

Conditions
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Multiple Trauma, Pain, Acute

Intervention / Treatment
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* Drug: Placebo
* Drug: Ketamine
* Drug: Fentanyl


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control (Placebo+ Standard of Care))<br> | Drug: Placebo<br>* Distilled water<br>|
| Active Comparator: Ketamine + Standard of Care<br> | Drug: Ketamine<br>* 1 mg/kg intranasal ketamine<br>|
| Active Comparator: Fentanyl + Standard of Care<br> | Drug: Fentanyl<br>* 1μg/kg intranasal fentanyl<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue score | a scale for measuring the extent of pain relief | Change from baseline at 40 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Blood oxygen saturation | Change from baseline at 40 minutes |