Intranasal Ketamine Versus Intranasal Fentanyl

• Sponsor: Isfahan University of Medical Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT04414800
• Collaborator: (none)
• Enrollment: 125
• Location: 1
• Arms: 3
• Actual Duration (Months): 12.5
• Patients Per Site Per Month: 10

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Trauma; Pain, Acute	Drug: Placebo; Drug: Ketamine; Drug: Fentanyl	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 125 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Intranasal Ketamine Versus Intranasal Fentanyl on Pain Management in Isolated Traumatic Patients
• Actual Study Start Date: Apr 1, 2017
• Actual Primary Completion Date: Mar 20, 2018
• Actual Study Completion Date: Apr 15, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Visual analogue score [Change from baseline at 40 minutes]

   a scale for measuring the extent of pain relief

Secondary Outcome Measures

1. Heart rate (HR) [Change from baseline at 40 minutes]

2. Blood pressure (BP) [Change from baseline at 40 minutes]

3. Respiratory rate (RR) [Change from baseline at 40 minutes]

4. SPO2 [Change from baseline at 40 minutes]

   Blood oxygen saturation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Al-Zahra University Hospital	Isfahan		Iran, Islamic Republic of	8138938728

Sponsors and Collaborators

• Isfahan University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mehdi Nasr Isfahani, Dr., Isfahan University of Medical Sciences
• ClinicalTrials.gov Identifier: NCT04414800
• Other Study ID Numbers: 396828
• First Posted: Jun 4, 2020
• Last Update Posted: Jun 4, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Acute Pain; Multiple Trauma; Fentanyl; Ketamine

Study Results

No Results Posted as of Jun 4, 2020