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Completed

NCT Number: NCT04414800

Intranasal Ketamine Versus Intranasal Fentanyl

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.

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Key information

Conditions

Multiple Trauma Acute Pain Neurologic Manifestations Pain Pain, Acute Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

15 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Al-Zahra University Hospital

Isfahan, 8138938728, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Distilled water

ketamine

Drug

1 mg/kg intranasal ketamine

Fentanyl

Drug

1μg/kg intranasal fentanyl

Primary outcomes

  1. Visual analogue score

    Time frame: Change from baseline at 40 minutes

    a scale for measuring the extent of pain relief

Secondary outcomes

  1. Heart rate (HR)

    Time frame: Change from baseline at 40 minutes

  2. Blood pressure (BP)

    Time frame: Change from baseline at 40 minutes

  3. Respiratory rate (RR)

    Time frame: Change from baseline at 40 minutes

  4. SPO2

    Time frame: Change from baseline at 40 minutes

    Blood oxygen saturation

Sponsors and collaborators

Lead sponsor

Isfahan University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 4, 2020
Registry last updated
Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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