Intranasal Ketamine Versus Intranasal Fentanyl

NCT04414800 | Completed Phase 3

• 1 other identifier: 396828
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Trauma; Pain, Acute

Outcome Measures

Primary Outcomes (1)

• Visual analogue score

  a scale for measuring the extent of pain relief

  Change from baseline at 40 minutes

Secondary Outcomes (4)

• 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

Study Arms (3)

Control (Placebo+ Standard of Care))

PLACEBO COMPARATOR

Drug: Placebo

Ketamine + Standard of Care

ACTIVE COMPARATOR

Drug: Ketamine

Fentanyl + Standard of Care

ACTIVE COMPARATOR

Drug: Fentanyl

Interventions

Placebo DRUG

Distilled water

Control (Placebo+ Standard of Care))

Ketamine DRUG

1 mg/kg intranasal ketamine

Ketamine + Standard of Care

Fentanyl DRUG

1μg/kg intranasal fentanyl

Fentanyl + Standard of Care

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Isfahan University of Medical Sciences: lead

Study Sites (1)

Al-Zahra University Hospital

Isfahan, 8138938728, Iran

Location

MeSH Terms

Conditions

Multiple Trauma; Acute Pain

Interventions

Ketamine; Fentanyl

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: June 4, 2020
• Study Start: April 1, 2017
• Primary Completion: March 20, 2018
• Study Completion: April 15, 2018
• Last Updated: June 4, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)