Low-Dose Intravenous Ketamine Bolus Versus Conventional Technique
1 other identifier
interventional
198
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2017
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 17, 2017
CompletedFirst Submitted
Initial submission to the registry
March 15, 2018
CompletedFirst Posted
Study publicly available on registry
April 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 28, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 14, 2018
CompletedApril 17, 2018
April 1, 2018
1.3 years
March 15, 2018
April 9, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Sedation depth
By Ramsey sedation scale. With score 1 for restlessness to score 6 for unresponsiveness.
30 minutes
Study Arms (2)
Ketamine Hydrochloride 50Mg/1mL
EXPERIMENTALIn 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.
Ketamine Hydrochloride 50Mg/mL
EXPERIMENTALin 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Al-Zahra University Hospital
Isfahan, 8138938728, Iran
Mehdi Nasr Isfahani
Isfahan, 8194856781, Iran
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mehdi Nasr Isfahani, M.D.
Isfahan University of Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 15, 2018
First Posted
April 17, 2018
Study Start
January 17, 2017
Primary Completion
April 28, 2018
Study Completion
May 14, 2018
Last Updated
April 17, 2018
Record last verified: 2018-04