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Intranasal Ketamine Versus Intranasal Fentanyl

Primary Purpose

Multiple Trauma, Pain, Acute

Status

Completed

Phase

Phase 3

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Placebo

Ketamine

Fentanyl

About this trial

This is an interventional treatment trial for Multiple Trauma

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Al-Zahra University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control (Placebo+ Standard of Care))

Ketamine + Standard of Care

Fentanyl + Standard of Care

Arm Description

Outcomes

Primary Outcome Measures

Visual analogue score

a scale for measuring the extent of pain relief

Secondary Outcome Measures

Heart rate (HR)

Blood pressure (BP)

Respiratory rate (RR)

SPO2

Blood oxygen saturation

Full Information

NCT ID

NCT04414800

First Posted

May 22, 2020

Last Updated

June 2, 2020

Sponsor

Isfahan University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT04414800

Brief Title

Intranasal Ketamine Versus Intranasal Fentanyl

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

April 1, 2017 (Actual)

Primary Completion Date

March 20, 2018 (Actual)

Study Completion Date

April 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Isfahan University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Trauma, Pain, Acute

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

125 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control (Placebo+ Standard of Care))

Arm Type

Placebo Comparator

Arm Title

Ketamine + Standard of Care

Arm Type

Active Comparator

Arm Title

Fentanyl + Standard of Care

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Distilled water

Intervention Type

Drug

Intervention Name(s)

Ketamine

Intervention Description

1 mg/kg intranasal ketamine

Intervention Type

Drug

Intervention Name(s)

Fentanyl

Intervention Description

1μg/kg intranasal fentanyl

Primary Outcome Measure Information:

Title

Visual analogue score

Description

a scale for measuring the extent of pain relief

Time Frame