Low Dose Ketamine Intra Nasal Traumatology

NCT ID: NCT03233035

Last Updated: 2019-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 1102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2018-12-01

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.

Detailed 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

Conditions

Trauma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

placebo group

Intranasal placebo pulverisation

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Ketamine group

Intranasal ketamine pulverisation

Group Type: ACTIVE_COMPARATOR

Ketamine

Intervention Type: DRUG

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

Interventions

Ketamine

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

normal saline solution

Eligibility Criteria

Inclusion Criteria

• 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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Monastir

OTHER

Sponsor Role: lead

Responsible Party

Pr. Semir Nouira

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nouira Semir, Professor

Role: PRINCIPAL_INVESTIGATOR

university Hospital of Monastir

Locations

Nouira Samir

Monastir, Emergency Department Monastir, Tunisia 5000, Tunisia

Emergency department of university hospital Fattouma Bourguiba of Monastir

Monastir, , Tunisia

Countries

Tunisia

Other Identifiers

Ket-Int-Nas-TR

Identifier Type: -

Identifier Source: org_study_id