Intranasal Ketamine Versus Intranasal Fentanyl

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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Acute; Multiple Trauma
• Intervention / Treatment: Drug: Placebo; Drug: Ketamine; Drug: Fentanyl

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Phase 3

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Isfahan, Iran, Islamic Republic of, 8138938728
    • Al-Zahra University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 65 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Isfahan University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): March 20, 2018
• Study Completion (Actual): April 15, 2018

Study Registration Dates

• First Submitted: May 22, 2020
• First Submitted That Met QC Criteria: June 2, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: June 2, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Acute Pain; Multiple Trauma; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Ketamine; Fentanyl
• Other Study ID Numbers: 396828

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: It will be possible to share data if requested

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No