Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

Intranasal ketamine for treatment of acute pain in the emergency department : A randomized controlled trial

Introduction :

Pain is the most common complaint for emergency department (ED) visits [1].The provision of adequate, safe, and timely analgesia is a core component of patient care in the emergency department (ED). Ketamine is a noncompetitive Nmethyl- D-aspartate and glutamate receptor antagonist that decreases central sensitization, "wind-up" phenomena, and pain memory [2,3].

At subdissociative doses (0.1 to 0.6 mg/kg; most commonly 0.3 mg/kg) maintains potent analgesic and amnestic effects that are accompanied by preservation of protective airway reflexes, spontaneous respiration, and cardiopulmonary stability [4-6].

Intranasal route ….

Objective of the study :

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 class III analgesic agents.

Materials and Methods :

Study design :

It is a ramdomized, prospective, double blind, controlled, multicentric trial. The study is registered with clinical.tria.gov (…….).

Study Setting and Selection of Participants :

The trial is conducted in three community teaching hospitals :

- Emergency department, fattouma bourguiba university hospital, monastir, tunisia

- Emergency department, sahloul university hospital, sousse, tunisia

- Emergency department, farhat hached university hospital, sousse, tunisia

ED principal investigators maintain the randomization list, which is generated before the start of the study, prepare the medication, and deliver it to the treating physician in a blinded manner.

Inclusion criteria :

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

Exclusion criteria :

- 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.

Protocol :

In the triage area, each patient having the inclusion criteria receives 25mg of ketamine in 0.5 ml of serum saline in one pulverisation per nostril or 0.5 mL of normal saline solution in one pulverisation per nostril as a placebo according to the predetermined randomization list. None of the treating physician or nurses is aware about the medication received. In all patients included, the investigators collect vital signs ; demographic and clinical data.

Study investigators record VAS, and adverse effects at 15, 30, 60, 90, and 120 minutes.

At 30 minutes, if patients report a pain numeric rating scale score of 5 or greater and request additional pain relief, titrated morphine is administered as a rescue analgesic with a dose of 0.1 mg/Kg repeated every 3 to 5 minutes if the pain numeric rating scale score is still greater or equal to 3.

All data recorded on data collection sheets, including sex, demographics, medical history, and vital signs, were entered into SPSS (version 20.0; IBM Corp) by the research manager.

Patients's informed consent is obtained. The ethic commitee of our institution approved the study.

Endpoints :

Primary endpoints :

- Need for rescue opioids during ED stay

Secondary endpoints :

- requirement of non-opioids analgesic agents.

- percentage of patients discharged from the ED with VAS <30.

- Safety : adverse events ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03233035
Study type Interventional
Source University of Monastir
Contact
Status Completed
Phase Phase 2
Start date January 1, 2018
Completion date December 1, 2018

See also
  Status Clinical Trial Phase
Recruiting NCT04848376 - Post-Market Clinical Follow-up Study of A-SPINE's Products
Terminated NCT03781817 - Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures Phase 4
Completed NCT04342416 - Using a Brief Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women N/A
Recruiting NCT04856449 - DBT Skills Plus EMDR for BPD and Trauma N/A
Completed NCT04356963 - Adjunct VR Pain Management in Acute Brain Injury N/A
Completed NCT05669313 - The Effects of Hypothermia and Acidosis on Coagulation During Treatment With Rivaroxaban Measured With ROTEM
Active, not recruiting NCT03622632 - Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
Recruiting NCT04725721 - Testing FIRST in Youth Outpatient Psychotherapy N/A
Active, not recruiting NCT05530642 - An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel N/A
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Not yet recruiting NCT03696563 - FreeO2 PreHospital - Automated Oxygen Titration vs Manual Titration According to the BLS-PCS N/A
Withdrawn NCT03249129 - Identification of Autoantibodies and Autoantigens in the Cerebrospinal Fluid of Patients With Spinal Cord Trauma
Completed NCT02240732 - Surgical Tourniquets and Cerebral Emboli N/A
Completed NCT02227979 - Effects of PURPLE Cry Intervention N/A
Withdrawn NCT01169025 - Fentanyl vs. Low-Dose Ketamine for the Relief of Moderate to Severe Pain in Aeromedical Patients N/A
Recruiting NCT01812941 - Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients N/A
Completed NCT03112304 - Child STEPS for Youth Mental Health in Maine Sustainability N/A
Completed NCT01475344 - Fibrinogen Concentrate (FGTW) in Trauma Patients, Presumed to Bleed (FI in TIC) Phase 1/Phase 2
Completed NCT01201863 - Neuroendocrine Dysfunction in Traumatic Brain Injury: Effects of Testosterone Therapy Phase 4
Completed NCT01210417 - Trauma Heart to Arm Time N/A