Intranasal Ketamine Versus Intranasal Fentanyl

Phase 3

Completed

• Conditions: Multiple Trauma; Pain, Acute
• Interventions: Drug: Placebo; Drug: Ketamine; Drug: Fentanyl

• Registration Number: NCT04414800
• Lead Sponsor: Isfahan University of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-01
• Primary Completion: 2018-03-20
• Study Completion: 2018-04-15
• Status Verified: 2020-05
• Study First Submitted: 2020-05-22
• Study First Submitted QC: 2020-06-02
• Last Update Submitted: 2020-06-02
• Study First Posted: 2020-06-04
• Last Update Posted: 2020-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control (Placebo+ Standard of Care))	Placebo	-
Ketamine + Standard of Care	Ketamine	-
Fentanyl + Standard of Care	Fentanyl	-

Primary Outcome Measures

Name	Time	Method
Visual analogue score	Change from baseline at 40 minutes	a scale for measuring the extent of pain relief

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Al-Zahra University Hospital; 🇮🇷 Isfahan, Iran, Islamic Republic of