Procedural SedationPhase 2/3NCT03499886
Low-Dose Intravenous Ketamine Bolus Versus Conventional Technique
A Phase 2/3 study testing Ketamine Hydrochloride 50Mg/1mL Solution for Injection and Ketamine Hcl 50Mg/Ml Inj in people with Procedural Sedation, run by Isfahan University of Medical Sciences at 2 sites in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Procedural Sedation
- What is being tested?
- Ketamine Hydrochloride 50Mg/1mL Solution for Injection and Ketamine Hcl 50Mg/Ml Inj
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 2 sitesIran
- Study dates
- 17 Jan 2017to 14 May 2018
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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- Patients who have withdrawn from the study, or those receiving benzodiazepines and other sedative drugs within 6 hours prior to enrollment.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.
Trial locations and contacts
2 sites in 1 country.
Iran2 sites, 1 recruiting
- Completed
Al-Zahra University Hospital
Isfahan, 8138938728
- Recruiting
Mehdi Nasr Isfahani
Isfahan, 8194856781
Mehdi Nasr Isfahani, m_nasr54@yahoo.com
mni.papillon@gmail.com
About this study
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
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).
Read the 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.
- Conditions
- Procedural Sedation
- Being tested
- Ketamine Hydrochloride 50Mg/1mL Solution for Injection, Ketamine Hcl 50Mg/Ml Inj
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine Hydrochloride 50Mg/1mL Solution for InjectionDrug
Also called Ketalar
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.
Ketamine Hcl 50Mg/Ml InjDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine Hydrochloride 50Mg/1mL | Experimental | 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. Receives: Drug: Ketamine Hydrochloride 50Mg/1mL Solution for Injection |
| Ketamine Hydrochloride 50Mg/mL | Experimental | 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. Receives: Drug: Ketamine Hcl 50Mg/Ml Inj |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sedation depth
By Ramsey sedation scale. With score 1 for restlessness to score 6 for unresponsiveness.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start17 Jan 2017
- Primary completion28 Apr 2018 (estimated)
- Study completion14 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural SedationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehdi Nasr Isfahani, Isfahan University of Medical Sciences
- Investigators
- Mehdi Nasr Isfahani, M.D., Principal investigator, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03499886
- Sponsor's protocol ID
- 195027
- Status last verified
- Apr 2018
- First submitted
- 15 Mar 2018
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03499886
- Acronym / sponsor ID
- 195027
- Conditions
- Procedural Sedation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- 17 Jan 2017 (actual)
- Primary completion
- 28 Apr 2018 (estimated)
- Study completion
- 14 May 2018 (estimated)
- First posted
- 17 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine Hydrochloride 50Mg/1mL | Experimental | Drug: Ketamine Hydrochloride 50Mg/1mL Solution for InjectionIn 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 | Experimental | Drug: Ketamine Hcl 50Mg/Ml Injin 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. |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamine Hydrochloride 50Mg/1mL Solution for InjectionAlso: KetalarIn 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. | Drug | Ketamine Hydrochloride 50Mg/1mL |
| Ketamine Hcl 50Mg/Ml InjIn 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. | Drug | Ketamine Hydrochloride 50Mg/mL |
Primary outcome
Sedation depth
Time frame: 30 minutes
By Ramsey sedation scale. With score 1 for restlessness to score 6 for unresponsiveness.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehdi Nasr Isfahani, M.D. principal investigator
Isfahan University of Medical Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ketamine Hydrochloride 50Mg/1mL Solution for Injection and Ketamine Hcl 50Mg/Ml Inj in people with Procedural Sedation, run by Isfahan University of Medical Sciences at 2 sites in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mehdi Nasr Isfahani, M.D. (+989132034381, mni.papillon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sedation depth (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018; AzTrials last refreshed its copy on 1 Nov 2026.