Intranasal Ketamine Versus Intranasal Fentanyl

• Status: Completed
• Trial end date: 2018-04-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Isfahan University of Medical Sciences
• Treatments: Fentanyl; Ketamine

Criteria

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