Intranasal Ketamine Versus Intranasal Fentanyl

Isfahan University of Medical Sciences

Status and phase: Completed; Phase 3

Conditions: Multiple Trauma; Pain, Acute

Treatments: Drug: Ketamine; Drug: Fentanyl; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04414800

396828

Details and patient eligibility

About

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.

Enrollment: 125 patients

Sex: All

Ages: 15 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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125 participants in 3 patient groups, including a placebo group

Control (Placebo+ Standard of Care))

Placebo Comparator group

Treatment:

Drug: Placebo

Ketamine + Standard of Care

Active Comparator group

Treatment:

Drug: Ketamine

Fentanyl + Standard of Care

Active Comparator group

Treatment:

Drug: Fentanyl