Low-Dose Intravenous Ketamine Bolus Versus Conventional Technique

April 9, 2018 updated by: Mehdi Nasr Isfahani, Isfahan University of Medical Sciences

Low-Dose Intravenous Ketamine Bolus Versus Conventional Technique for Reduction of Upper and Lower Extremity Fractures in Children: A Randomized Controlled Clinical Trial

Abstract Background: Ketamine has been introduced as one of the most common drugs, administered to sedate children for different painful procedures in the emergency department (ED) but administration in higher dosage causes some severe complications. Thus, the aim of this study was to evaluate the effect of low-dose intravenous ketamine bolus versus conventional injection for reduction of upper and lower extremity fractures in children.

Materials and Methods: In this randomized clinical trial, 198 participants with upper and lower extremity fractures were enrolled. The participants were divided randomly into two groups. In the intervention group, ketamine 1% was administered rapidly at a dose of 0.5 mg / kg (within 5 seconds), and in the control group, ketamine 1.5 mg / kg was slowly injected for 30 to 60 seconds. Then outcomes such as sedation depth and complications were measured for every two minutes and satisfaction of participants and physicians were recorded.

Results: Results showed that the successful sedation rate in the low dose ketamine group was significantly lower, as compared to the control group (7% vs 100%) (p<0.001). Moreover, In terms of duration of drug effect and of recovery, the low dose ketamine group were significantly lower compared with the group receiving higher dosage of ketamine (p<0.05). Furthermore, the sedation depth based on Wisconsin Sedation Scale was significantly higher, in the low dose ketamine group compared to the other group. By evaluating different complications, we found that the rate of neurological (20.4 % vs 5%) and physiological (10.2% vs 2%) complications in the control group was significantly higher compared to the group receiving low-dose ketamine (p<0.05).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This prospective double-blind clinical trial was conducted in the ED of Isfahan Al-Zahra Hospital, from May 2016 to June 2017. The sedation levels and different outcomes of patients receiving low-dose intravenous ketamine bolus (intervention group) were compared to patients receiving higher doses of intravenous ketamine (control group), for reduction of upper and lower extremity fractures. Inclusion criteria consisted of parents' desire and consent to participate in the study, body mass index (BMI) within the normal range, having age of 6 months to 17 years, requiring a reduction of upper and lower limb fractures, not receiving benzodiazepines and other sedative drugs before intervention.

Exclusion criteria consisted of patients' age <3 months with the body temperature of > 38 ̊C, due to upper respiratory tract infection. Patients having any other complications such as cardiovascular, gastrointestinal, psychological and neurological were excluded from the study. We also excluded the patients who have withdrawn from the study.

Participants and Intervention The study flowchart is shown in figure 1. Two hundreds ten patients with a diagnosis of upper and lower extremity fractures, diagnosed by Emergency Medicine Specialist, were enrolled based on clinical and para-clinical images and inclusion criteria.

The participants were randomly allocated into two groups, using a block randomization procedure with matching subjects in each block based on sex and age. One hundred ninety eight patients completed the study; including one hundred from the intervention group and 98 from the control group. The study received ethics approval from the Ethics Committee of Isfahan University of Medical Sciences (--------------), and all participants and their parents signed the informed consent form.

After obtaining informed consent, eligible patients were enrolled. All patients were monitored by direct observation and continuous cardiovascular monitoring, in order to check the vital signs and also by pulse Oximeters to examine the blood oxygen saturation level.

Study Type

Interventional

Enrollment (Anticipated)

198

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 17 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Parents' desire and consent to participate in the study
  • Body mass index (BMI) within the normal range
  • Having age of 6 months to 17 years
  • Requiring a reduction of upper and lower limb fractures.
  • Subjects who did not complete study endpoints, however, were included as part on an intention to treat analysis.

Exclusion Criteria:

  • Age <6 months
  • Body temperature of > 38 ̊C, due to upper respiratory tract infection.
  • Participants having any other complications such as cardiovascular, gastrointestinal, psychological and neurological .
  • Patients who have withdrawn from the study, or those receiving benzodiazepines and other sedative drugs within 6 hours prior to enrollment.
  • Subjects who refused to give consent or those who were judged by investigator as non eligible were excluded as well.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ketamine Hydrochloride 50Mg/1mL
In the intervention group, "Ketamine Hydrochloride 50Mg/1mL" was administered rapidly at a dose of 0.5 mg / kg (within 5 seconds). Patient assessment was performed before and two minutes after ketamine injection, and then every 5 minutes after the reduction of the fracture, by an anesthetist blind to the type of intervention.
Drug: Ketamine Hydrochloride 50Mg/1mL Solution for Injection
In the intervention group, ketamine 1% was administered rapidly at a dose of 0.5 mg / kg (within 5 seconds), and in the control group, ketamine 1.5 mg / kg was slowly injected for 30 to 60 seconds.
Other Names:
  • Ketalar
EXPERIMENTAL: Ketamine Hydrochloride 50Mg/mL
in the control group, ketamine 1.5 mg / kg was slowly injected for 30 to 60 seconds. Patient assessment was performed before and two minutes after ketamine injection, and then every 5 minutes after the reduction of the fracture, by an anesthetist blind to the type of intervention.
Drug: Ketamine Hcl 50Mg/Ml Inj
In the intervention group, ketamine 1% was administered rapidly at a dose of 0.5 mg / kg (within 5 seconds), and in the control group, ketamine 1.5 mg / kg was slowly injected for 30 to 60 seconds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sedation depth
Time Frame: 30 minutes
By Ramsey sedation scale. With score 1 for restlessness to score 6 for unresponsiveness.
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isfahan University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 17, 2017

Primary Completion (ANTICIPATED)

April 28, 2018

Study Completion (ANTICIPATED)

May 14, 2018

Study Registration Dates

First Submitted

March 15, 2018

First Submitted That Met QC Criteria

April 9, 2018

First Posted (ACTUAL)

April 17, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 17, 2018

Last Update Submitted That Met QC Criteria

April 9, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 195027

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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