Low Dose Ketamine Intra Nasal Traumatology

NCT03233035 | Completed Phase 2 DMC

• 1 other identifier: Ket-Int-Nas-TR
• Study Type: interventional
• Target: 1,102
• Locations: 1 country
• Sites: 2

Brief Summary

To evaluate the efficacy and safety of early administration of low-dose intranasal ketamine analgesic agents in patients with moderate to severe pain in the ED in reducing the need for opioid or non opioids analgesic agents.

Conditions

Trauma

Keywords

Ketamine-Intranasal-Acute pain-Emergency departement

Outcome Measures

Primary Outcomes (1)

• Number and percentage of patients who need rescue opiods in the two groups

  the need for rescue opioids during ED stay

  30 minutes

Secondary Outcomes (3)

• Intolerance to treatement and adverse events

  30 minutes and at 120 minutes

• Percentage of patients with VAS <30 mm at discharge

  120 minutes

• Number and percentage of patients who required non opiods analgesics

  30 minutes

Study Arms (2)

placebo group

PLACEBO COMPARATOR

Intranasal placebo pulverisation

Drug: Placebo

Ketamine group

ACTIVE COMPARATOR

Intranasal ketamine pulverisation

Drug: Ketamine

Interventions

Ketamine DRUG

25mg of ketamine in 0.5 ml of serum saline in one pulverisation per nostril is received

Ketamine group

Placebo DRUG

0.5 mL of normal saline solution as a placebo in one pulverisation per nostril

Also known as: normal saline solution

placebo group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The study includes patients aged 18 to 80 years who presented to the ED with acute limb trauma pain with a visual analgesic scale (VAS) of 5 or more on a standard 11- point (0 to 10). An informed consent is necessary.

You may not qualify if:

• \- Pregnancy,
• Breast-feeding,
• Altered mental status,
• Allergy to ketamine or morphine or
• Weight less than 46 kg or greater than 115 kg,
• Unstable vital signs (systolic blood pressure \<90 or \>180 mm Hg, pulse rate \<50 or \>150 beats/min, and respiration rate \<10 or \>30 breaths/min),
• Medical history of acute head or eye injury, seizure, intracranial hypertension, chronic pain, severre renal or hepatic insufficiency,
• Alcohol or drug abuse,
• Psychiatric illness,
• Recent (4 hours before) analgesic agent use.

Sponsors & Collaborators

• University of Monastir: lead

Study Sites (2)

Nouira Samir

Monastir, Emergency Department Monastir, Tunisia 5000, 5000, Tunisia

Location

Emergency department of university hospital Fattouma Bourguiba of Monastir

Monastir, 5000, Tunisia

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Ketamine; Saline Solution

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Nouira Semir, Professor

  university Hospital of Monastir

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Ketamine versus placebo as a double blind study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Double Blind Study

Study Record Dates

• First Submitted: May 14, 2017
• First Posted: July 28, 2017
• Study Start: January 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: July 2, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)