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Low-Dose Intravenous Ketamine Bolus Versus Conventional Technique

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ClinicalTrials.gov Identifier: NCT03499886
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Mehdi Nasr Isfahani, Isfahan University of Medical Sciences

Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Procedural Sedation Drug: Ketamine Hydrochloride 50Mg/1mL Solution for Injection Drug: Ketamine Hcl 50Mg/Ml Inj Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Low-Dose Intravenous Ketamine Bolus Versus Conventional Technique for Reduction of Upper and Lower Extremity Fractures in Children: A Randomized Controlled Clinical Trial
Actual Study Start Date : January 17, 2017
Estimated Primary Completion Date : April 28, 2018
Estimated Study Completion Date : May 14, 2018

Resource links provided by the National Library of Medicine


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 Name: 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.




Primary Outcome Measures :
  1. Sedation depth [ Time Frame: 30 minutes ]
    By Ramsey sedation scale. With score 1 for restlessness to score 6 for unresponsiveness.



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Ages Eligible for Study:   6 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499886


Contacts
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Contact: Mehdi Nasr Isfahani, M.D. +989132034381 mni.papillon@gmail.com

Locations
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Iran, Islamic Republic of
Al-Zahra University Hospital Completed
Isfahan, Iran, Islamic Republic of, 8138938728
Mehdi Nasr Isfahani Recruiting
Isfahan, Iran, Islamic Republic of, 8194856781
Contact: Mehdi Nasr Isfahani       m_nasr54@yahoo.com   
Contact       mni.papillon@gmail.com   
Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
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Principal Investigator: Mehdi Nasr Isfahani, M.D. Isfahan University of Medical Sciences

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Responsible Party: Mehdi Nasr Isfahani, Principal Investigator, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03499886     History of Changes
Other Study ID Numbers: 195027
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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

Additional relevant MeSH terms:
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Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action