Intranasal Ketamine Versus Intranasal Fentanyl

Pain, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04414800
• Other study ID #: 396828
• Status: Completed
• Phase: Phase 3
• Start date: April 1, 2017
• Est. completion date: April 15, 2018

Study information

• Verified date: May 2020
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: April 15, 2018
• Est. primary completion date: March 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Multiple Trauma
• Pain, Acute

Intervention

Drug:
• Placebo
Distilled water
• Ketamine
1 mg/kg intranasal ketamine
• Fentanyl
1µg/kg intranasal fentanyl

Locations

Country	Name	City	State
Iran, Islamic Republic of	Al-Zahra University Hospital	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue score	a scale for measuring the extent of pain relief	Change from baseline at 40 minutes
Secondary	Heart rate (HR)		Change from baseline at 40 minutes
Secondary	Blood pressure (BP)		Change from baseline at 40 minutes
Secondary	Respiratory rate (RR)		Change from baseline at 40 minutes
Secondary	SPO2	Blood oxygen saturation	Change from baseline at 40 minutes