Moderate, Deep SedationPhase 4NCT02519595
Optimal Dosing of Ketamine for Procedural Sedation and Analgesia in Children
A Phase 4 study testing Ketamine IV 1mg/kg, Ketamine IV 1.5mg/kg and Ketamine IV 2mg/kg in people with Moderate, Deep Sedation, run by Children's Hospital of Michigan.
Trial summary
There is a wide variation of published IV ketamine dosing regimens used for procedural sedation in children in the Emergency Department (ED). The purpose of the study was to compare the efficacy, duration of sedation and adverse events between the three commonly administered doses of IV ketamine (1 mg/kg, 1.5 mg/kg… Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Moderate, Deep Sedation
- What is being tested?
- Ketamine IV 1mg/kg, Ketamine IV 1.5mg/kg and Ketamine IV 2mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Aug 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children 3 -18 years of age
- Belonging to American Society of Anesthesiologists (ASA) classification 1 or 2
- Receiving IV ketamine for procedural sedation for orthopedic procedures,
- Incision and Drainage of skin abscess and laceration repair
Who cannot join
- Contraindications to use of Ketamine
- Parents or legal guardian not available or declined to provide informed consent
- Child declined to provide assent,
- Patients that received intramuscular ketamine,
- Patient that received benzodiazepines in addition to ketamine
- Children weighing >100 kilogram
- Children with developmental disabilities.
About this study
There is a wide variation of published IV ketamine dosing regimens used for procedural sedation in children in the Emergency Department (ED). The purpose of the study was to compare the efficacy, duration of sedation and adverse events between the three commonly administered doses of IV ketamine (1 mg/kg, 1.5 mg/kg and 2 mg/kg) using the traditional administration method of 30-60 second infusion for ED sedation in children.
Read the detailed description
This was a prospective, double-blind, randomized controlled trial of children aged 3 to 18 years who received IV ketamine for procedural sedation and analgesia (PSA) for orthopedic procedures, incision and drainage (I \& D) of skin abscess and laceration repair in an inner city, tertiary care pediatric ED. Random sequence allocation was performed using a computer-generated, random number table by the study research pharmacist. The study participants were grouped according to their age as follows (1) 3-6 years (2) 7-12 years (3) 13-18 years. Children from each age group were assigned in equal numbers to all three ketamine dosing (1 mg/kg, 1.5 mg/kg and 2 mg/kg) groups using random permuted blocks stratified by the pharmacist. All ED staff including the physician and the nurse in charge of sedation, the study research assistant, the parents/guardians and the study subjects were blinded to the randomization and the group assignments. The dosage and administration of additional doses of ketamine were left to the discretion of the ED physician in charge of the sedation. The research team did not participate in the clinical care including sedation of the patient. Children were monitored per ED policy for the entire duration of sedation. Three 1 ml blood samples for the ketamine assay was collected from the existing intravenous access at three time intervals: 3-5 minutes after ketamine administration, at midpoint during the procedure and prior to discharge of the patient from the ED. In the event a second dose of ketamine was administered, a 4th 1 ml sample was collected 3-5 minutes after the 2nd dose in children weighing >20 kilograms. Patient demographics, procedure type, NPO status , ASA classification, pain medication administered prior to sedation (timing, dosage and type), number and total doses of ketamine administered after the initial study dose, sedation efficacy and duration, length of procedure, adverse events related to sedation, interventions performed to address the adverse events and patient disposition were collected. The study research assistant also performed a follow up phone call to the parents/caregivers of the children 48 hours after ED discharge to collect information on adverse events that happened at home . A total of 3 attempts were made to contact the parent/caregiver after which the participant was considered as lost to followup.
- Conditions
- Moderate, Deep Sedation
- Being tested
- Ketamine IV 1mg/kg, Ketamine IV 1.5mg/kg, Ketamine IV 2mg/kg
- Keywords
- Procedural sedation, ketamine, children
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine IV 1mg/kgDrug
Intervention: Ketamine IV 1mg/kg
Ketamine IV 1.5mg/kgDrug
Intervention: Ketamine IV 1.5 mg/kg
Ketamine IV 2mg/kgDrug
Intervention: Ketamine IV 2 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| ketamine IV 1 mg/kg | Experimental | Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients Receives: Drug: Ketamine IV 1mg/kg |
| Ketamine IV 1.5 mg/kg | Experimental | Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients Receives: Drug: Ketamine IV 1.5mg/kg |
| Ketamine IV 2 mg/kg | Experimental | Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients Receives: Drug: Ketamine IV 2mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sedation Efficacy
Measure sedation depth using Ramsay Sedation Scale. Varies from 1-6 with 1: anxious, agitated, restless 2: Cooperative, oriented, tranquil 3: responsive to commands 4: Brisk response to light glabellar tap or auditory stimulus 5: Sluggish response to light glabellar tap or loud auditory stimulus 6 being no response to light glabellar tap or loud auditory stimulus. Higher the score, greater is the depth of sedation. Use of ketamine usually provides a depth of sedation of 5 or 6.
Measured: Participants will be assessed after study drug adminsitration and the maximum depth of sedation achieved recorded. Approximately 2 hours
Pain
Measure pain using self reported Wong Baker faces pain rating scale prior to sedation, during sedation and prior to discharge.The scale shows a series of faces ranging from a happy face at 0, "No hurt" to a crying face at 10 "Hurts worst". The patient must choose the face that best describes how they are feeling. The score has values of 0(no hurt), 2(hurts little bit), 4(hurts little more), 6(hurts even more), 8(hurts whole lot),10 (hurts worst). The patient chooses one number that describes the pain best (eg. Either a 2 or 4).
Measured: Patients will be assessed during the procedure after administration of sedation medicaiton. Approximately 30 minutes
Secondary outcomes (4)
Sedation Duration
Length of sedation was defined as the time duration from the administration of study medication until ready for discharge using standardized discharge criteria (Aldrete scoring >9) followed at our institution.
Measured: Patients will be assessed during the length of time from administration of sedation medication until ready for discharge, Approximately 3 hours
Additional Dose
Number of participants to whom additional doses of ketamine administered apart from the study dose
Measured: Patients will be assessed during procedure . Approximately 1 hours
Adverse Events
Adverse events secondary to sedation experienced by the patient and interventions performed to overcome them
Measured: Patients will be assessed after administration of medication until discharge and will have a follow up phone call 48 hours after discharge for 3 attempts. 5 days.,
Sedation Satisfaction
Consultants will be asked to rate their level of satisfaction with sedation on a Likert Scale of 1-3
Measured: At the end of the procedure. Approximately 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2015 (estimated)
- Study startAug 2010
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Moderate, Deep 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nirupama Kannikeswaran, Children's Hospital of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02519595
- Sponsor's protocol ID
- R1-2013-88
- Status last verified
- Aug 2016
- First submitted
- 5 Aug 2015
- Last updated
- 12 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Dosing of Ketamine for Procedural Sedation and Analgesia in Children
- ClinicalTrials.gov ID
- NCT02519595
- Acronym / sponsor ID
- R1-2013-88
- Conditions
- Moderate, Deep Sedation
- Keywords
- Procedural sedation, ketamine, children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Children's Hospital of MichiganUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 11 Aug 2015 (estimated)
- Results
- Posted 12 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is a wide variation of published IV ketamine dosing regimens used for procedural sedation in children in the Emergency Department (ED). The purpose of the study was to compare the efficacy, duration of sedation and adverse events between the three commonly administered doses of IV ketamine (1 mg/kg, 1.5 mg/kg and 2 mg/kg) using the traditional administration method of 30-60 second infusion for ED sedation in children.
Detailed description
This was a prospective, double-blind, randomized controlled trial of children aged 3 to 18 years who received IV ketamine for procedural sedation and analgesia (PSA) for orthopedic procedures, incision and drainage (I \& D) of skin abscess and laceration repair in an inner city, tertiary care pediatric ED. Random sequence allocation was performed using a computer-generated, random number table by the study research pharmacist. The study participants were grouped according to their age as follows (1) 3-6 years (2) 7-12 years (3) 13-18 years. Children from each age group were assigned in equal numbers to all three ketamine dosing (1 mg/kg, 1.5 mg/kg and 2 mg/kg) groups using random permuted blocks stratified by the pharmacist. All ED staff including the physician and the nurse in charge of sedation, the study research assistant, the parents/guardians and the study subjects were blinded to the randomization and the group assignments. The dosage and administration of additional doses of ketamine were left to the discretion of the ED physician in charge of the sedation. The research team did not participate in the clinical care including sedation of the patient. Children were monitored per ED policy for the entire duration of sedation. Three 1 ml blood samples for the ketamine assay was collected from the existing intravenous access at three time intervals: 3-5 minutes after ketamine administration, at midpoint during the procedure and prior to discharge of the patient from the ED. In the event a second dose of ketamine was administered, a 4th 1 ml sample was collected 3-5 minutes after the 2nd dose in children weighing >20 kilograms. Patient demographics, procedure type, NPO status , ASA classification, pain medication administered prior to sedation (timing, dosage and type), number and total doses of ketamine administered after the initial study dose, sedation efficacy and duration, length of procedure, adverse events related to sedation, interventions performed to address the adverse events and patient disposition were collected. The study research assistant also performed a follow up phone call to the parents/caregivers of the children 48 hours after ED discharge to collect information on adverse events that happened at home . A total of 3 attempts were made to contact the parent/caregiver after which the participant was considered as lost to followup.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ketamine IV 1 mg/kg | Experimental | Drug: Ketamine IV 1mg/kgIntervention: A blinded dose of 1mg/kg IV ketamine is administered to patients |
| Ketamine IV 1.5 mg/kg | Experimental | Drug: Ketamine IV 1.5mg/kgIntervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients |
| Ketamine IV 2 mg/kg | Experimental | Drug: Ketamine IV 2mg/kgIntervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Children 3 -18 years of age
- Belonging to American Society of Anesthesiologists (ASA) classification 1 or 2
- Receiving IV ketamine for procedural sedation for orthopedic procedures,
- Incision and Drainage of skin abscess and laceration repair
Key exclusion criteria (7 listed)
- Contraindications to use of Ketamine
- Parents or legal guardian not available or declined to provide informed consent
- Child declined to provide assent,
- Patients that received intramuscular ketamine,
- Patient that received benzodiazepines in addition to ketamine
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 IV 1mg/kgIntervention: Ketamine IV 1mg/kg | Drug | ketamine IV 1 mg/kg |
| Ketamine IV 1.5mg/kgIntervention: Ketamine IV 1.5 mg/kg | Drug | Ketamine IV 1.5 mg/kg |
| Ketamine IV 2mg/kgIntervention: Ketamine IV 2 mg/kg | Drug | Ketamine IV 2 mg/kg |
Primary outcome
Sedation Efficacy
Time frame: Participants will be assessed after study drug adminsitration and the maximum depth of sedation achieved recorded. Approximately 2 hours
Measure sedation depth using Ramsay Sedation Scale. Varies from 1-6 with 1: anxious, agitated, restless 2: Cooperative, oriented, tranquil 3: responsive to commands 4: Brisk response to light glabellar tap or auditory stimulus 5: Sluggish response to light glabellar tap or loud auditory stimulus 6 being no response to light glabellar tap or loud auditory stimulus. Higher the score, greater is the depth of sedation. Use of ketamine usually provides a depth of sedation of 5 or 6.
Pain
Time frame: Patients will be assessed during the procedure after administration of sedation medicaiton. Approximately 30 minutes
Measure pain using self reported Wong Baker faces pain rating scale prior to sedation, during sedation and prior to discharge.The scale shows a series of faces ranging from a happy face at 0, "No hurt" to a crying face at 10 "Hurts worst". The patient must choose the face that best describes how they are feeling. The score has values of 0(no hurt), 2(hurts little bit), 4(hurts little more), 6(hurts even more), 8(hurts whole lot),10 (hurts worst). The patient chooses one number that describes the pain best (eg. Either a 2 or 4).
4 secondary outcomes
Sedation Duration
Time frame: Patients will be assessed during the length of time from administration of sedation medication until ready for discharge, Approximately 3 hours
Additional Dose
Time frame: Patients will be assessed during procedure . Approximately 1 hours
Adverse Events
Time frame: Patients will be assessed after administration of medication until discharge and will have a follow up phone call 48 hours after discharge for 3 attempts. 5 days.,
Sedation Satisfaction
Time frame: At the end of the procedure. Approximately 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine IV 1mg/kg, Ketamine IV 1.5mg/kg and Ketamine IV 2mg/kg in people with Moderate, Deep Sedation, run by Children's Hospital of Michigan.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 12 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sedation Efficacy (time frame: Participants will be assessed after study drug adminsitration and the maximum depth of sedation achieved recorded. Approximately 2 hours). The study lists 2 primary outcomes in all. 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 12 Oct 2016.