Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00490997
Status:
COMPLETED
Last Update Posted:
2017-08-25
First Post:
2007-06-21
Brief Title:
KetaminePropofol vs Ketamine Alone for Pediatric Fracture Reduction
Sponsor:
Lawson Health Research Institute
Organization:
Lawson Health Research Institute
Study Overview
Official Title:
A Prospective Randomized Double Blind Evaluation of KetaminePropofol vs Ketamine Alone for Pediatric Extremity Fracture Reduction
Status:
COMPLETED
Status Verified Date:
2008-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to compare Ketamine-Propofol with Ketamine-only in a double-blind randomised controlled trial in a paediatric emergency department We believe that the combination of these two agents will provide a new and more effective option for procedural sedation in paediatric emergency department patients The hypothesis of the study is that paediatric emergency department patients requiring procedural sedation for an isolated orthopaedic injury with Ketamine-Propofol will have reduced total sedation time time to recovery complications and improved satisfaction scores compared to patients receiving Ketamine alone
Detailed Description:
Purpose Procedural sedation has become an essential skill for emergency physicians allowing for completion of painful procedures in a safe comfortable and efficient manner The ideal sedative agent would allow for an effective level of sedation rapid onset and offset absence of hemodynamic or respiratory compromise and lack of post procedural side effects A variety of agents have been studied for paediatric procedural sedation however no currently used agent meets all of these criteria 1
Background Ketamine and Propofol are two agents that have been well studied and are commonly utilized as single agents for sedation Ketamine is a dissociative agent that has amnestic and analgesic qualities It has the unique property of allowing for deep sedation with minimal effects on the patients respiratory drive Ketamine use does not cause hypotension and in fact can have a positive effect on blood pressure Ketamine has been extensively studied in paediatric sedation and has been found to be a safe and effective 234 Side effects associated with Ketamine use include post procedural nausea and vomiting and unpleasant emergence phenomena such as agitation or hallucinations Ketamine sedation can result in prolonged recovery times compared to other sedative agents and has a low rate of respiratory depression apnea and laryngospasm 1
Propofol is a sedative-hypnotic agent that has been popular for use in adult and paediatric procedural sedation for over a decade The agents rapid onset of effect and short duration of action allow for efficient sedation and recovery Propofol has antiemetic properties and post-procedural side effects are rare Caution must be used with Propofol as it can be associated with significant respiratory depression andor hypotension 1 The prolonged use of Propofol in children can produce acidosis but this is not a problem for single use for an acute painful procedure
A number of studies have demonstrated that the combination of Ketamine and Propofol for sedation is safe and effective with most of the data in adults or in adult-child studies with small number of children 56 The combination of the two agents appears to reduce side effects of each medication used alone and allows for a rapid recovery time A prospective case series of Canadian emergency department patients given Ketamine-Propofol for procedural sedation has recently been published 5 In this study 22 of the patients were children However to date there has been no targeted research published comparing Ketamine-Propofol head to head with any other presently utilized sedation regimen in a paediatric emergency department setting
Objective Hypothesis The objective of this study is to compare Ketamine-Propofol with Ketamine-only in a double-blind randomised controlled trial in a paediatric emergency department We believe that the combination of these two agents will provide a novel and more efficacious option for procedural sedation in paediatric emergency department patients The hypothesis of the study is paediatric emergency department patients requiring procedural sedation for an isolated orthopaedic injury with Ketamine-Propofol will have reduced total sedation time time to recovery complications and improved satisfaction scores compared to patients receiving Ketamine alone
Experimental Design This study will be a prospective double-blind randomised controlled clinical trial with an expected enrolment of approximately 140 patients from June-October 2007
n 2 Z1-α2 Z1-β2 σ2 2
n 2 196 0842 202 102
n 2 784 400 100
n 627 or 63 per group
Based on the calculation above 63 children are needed in each group to have an 80 chance of detecting a clinically meaningful difference in total sedation time of 10 minutes between the groups assuming an alpha of 005 and a standard deviation of 20 minutes We have added an additional 7 patients 10 to each group to account for potential drop-outs Written informed consent will be obtained from a parentguardian for all children that meet the study inclusion criteria Additionally all children over the age of eight will also be asked for their assent
Interventions After giving informed consent eligible patients will be assigned to either the Ketamine-Propofol group or Ketamine-placebo group through random allocation Sealed envelopes containing a randomized assignment to either Ketamine-Propofol or Ketamine-only group will be prepared by an individual unconnected with the study using a web-based random number generator balanced to ensure equal allocation to each group
Patients in the Ketamine-only group will receive an intravenous dose of 10 mgkg Ketamine and patients in the Ketamine-Propofol group will receive an intravenous dose of 05 mgkg Ketamine and 10 mgkg Propofol at time zero Two minutes after the initial dose of sedative agent and every 2 minutes thereafter the attending physician will assess the patients level of sedation using the Childrens Hospital of Wisconsin Sedation Scale Appendix A If the attending physician determines the level of sedation is not adequate Sedation score 3 additional study drugs Ketamine group 025 mgkg Ketamine Ketamine-Propofol group 05 mgkg Propofol will be administered every 2 minutes until adequate sedation is achieved deep conscious sedation Childrens Hospital of Wisconsin Sedation Scale Score 3 Once a sedation score 3 is achieved the procedure will begin
All sedation will be performed under continuous cardiorespiratory monitoring based on current hospital guidelines under the care and surveillance of a pediatric emergency department registered nurse and physician Vital signs including heart rate blood pressure respiratory rate and oxygen saturation will be monitored continuously and recorded every 2 minutes with the exception of blood pressure which will be recorded every 4 minutes The assisting registered nurse will also record information regarding time of last liquid and solid intake and body weight on the hospitals standard procedural sedation and analgesia record form
A separate standardized datasheet Appendix B will be used to collect the time when the study drug was first administered the time when the procedure began the time the procedure was completed and the time to recovery Upon completion of the procedure a recovery score based on a modified Aldrete Scale will be recorded by a research associate blinded as to the intervention used every 2 minutes until full recovery defined as a minimum cumulative score of 8 The attending physician will be asked to document any complications including hypotension apnea hypoxia laryngospasm and pain on injection that occurred during the procedure and if any interventions were necessary The nurse caring for the patient will also record any adverse events nausea vomiting agitation that occurred during recovery
Outcome Measures The primary outcome will be total sedation time defined as the time that the first study drug was injected until the patient is fully recovered with a minimum recovery score 8 Secondary outcomes will include time to recovery patient nurse and physician satisfaction complications and adverse events The patient nurse and physician will be asked to individually assess their level of satisfaction with the sedation procedure using a 7-point Likert scale Appendices C-E
Analyses Strategy The independent samples t-test will be used to compare differences in mean total sedation time and recovery time between the Ketamine and Ketamine-Propofol groups The Mann-Whitney test will be used to compare differences in satisfaction levels measured on an ordinal scale between groups Differences in proportions of complications during the procedure and adverse events during recovery will be assessed by the Chi-Square test between groups A p value 005 will be considered statistically significant
Expectation The expectation of the study is paediatric emergency department patients requiring procedural sedation for an isolated orthopaedic injury with Ketamine-Propofol will have reduced total sedation time time to recovery complications and improved satisfaction scores compared to patients receiving Ketamine alone
Background Ketamine and Propofol are two agents that have been well studied and are commonly utilized as single agents for sedation Ketamine is a dissociative agent that has amnestic and analgesic qualities It has the unique property of allowing for deep sedation with minimal effects on the patients respiratory drive Ketamine use does not cause hypotension and in fact can have a positive effect on blood pressure Ketamine has been extensively studied in paediatric sedation and has been found to be a safe and effective 234 Side effects associated with Ketamine use include post procedural nausea and vomiting and unpleasant emergence phenomena such as agitation or hallucinations Ketamine sedation can result in prolonged recovery times compared to other sedative agents and has a low rate of respiratory depression apnea and laryngospasm 1
Propofol is a sedative-hypnotic agent that has been popular for use in adult and paediatric procedural sedation for over a decade The agents rapid onset of effect and short duration of action allow for efficient sedation and recovery Propofol has antiemetic properties and post-procedural side effects are rare Caution must be used with Propofol as it can be associated with significant respiratory depression andor hypotension 1 The prolonged use of Propofol in children can produce acidosis but this is not a problem for single use for an acute painful procedure
A number of studies have demonstrated that the combination of Ketamine and Propofol for sedation is safe and effective with most of the data in adults or in adult-child studies with small number of children 56 The combination of the two agents appears to reduce side effects of each medication used alone and allows for a rapid recovery time A prospective case series of Canadian emergency department patients given Ketamine-Propofol for procedural sedation has recently been published 5 In this study 22 of the patients were children However to date there has been no targeted research published comparing Ketamine-Propofol head to head with any other presently utilized sedation regimen in a paediatric emergency department setting
Objective Hypothesis The objective of this study is to compare Ketamine-Propofol with Ketamine-only in a double-blind randomised controlled trial in a paediatric emergency department We believe that the combination of these two agents will provide a novel and more efficacious option for procedural sedation in paediatric emergency department patients The hypothesis of the study is paediatric emergency department patients requiring procedural sedation for an isolated orthopaedic injury with Ketamine-Propofol will have reduced total sedation time time to recovery complications and improved satisfaction scores compared to patients receiving Ketamine alone
Experimental Design This study will be a prospective double-blind randomised controlled clinical trial with an expected enrolment of approximately 140 patients from June-October 2007
n 2 Z1-α2 Z1-β2 σ2 2
n 2 196 0842 202 102
n 2 784 400 100
n 627 or 63 per group
Based on the calculation above 63 children are needed in each group to have an 80 chance of detecting a clinically meaningful difference in total sedation time of 10 minutes between the groups assuming an alpha of 005 and a standard deviation of 20 minutes We have added an additional 7 patients 10 to each group to account for potential drop-outs Written informed consent will be obtained from a parentguardian for all children that meet the study inclusion criteria Additionally all children over the age of eight will also be asked for their assent
Interventions After giving informed consent eligible patients will be assigned to either the Ketamine-Propofol group or Ketamine-placebo group through random allocation Sealed envelopes containing a randomized assignment to either Ketamine-Propofol or Ketamine-only group will be prepared by an individual unconnected with the study using a web-based random number generator balanced to ensure equal allocation to each group
Patients in the Ketamine-only group will receive an intravenous dose of 10 mgkg Ketamine and patients in the Ketamine-Propofol group will receive an intravenous dose of 05 mgkg Ketamine and 10 mgkg Propofol at time zero Two minutes after the initial dose of sedative agent and every 2 minutes thereafter the attending physician will assess the patients level of sedation using the Childrens Hospital of Wisconsin Sedation Scale Appendix A If the attending physician determines the level of sedation is not adequate Sedation score 3 additional study drugs Ketamine group 025 mgkg Ketamine Ketamine-Propofol group 05 mgkg Propofol will be administered every 2 minutes until adequate sedation is achieved deep conscious sedation Childrens Hospital of Wisconsin Sedation Scale Score 3 Once a sedation score 3 is achieved the procedure will begin
All sedation will be performed under continuous cardiorespiratory monitoring based on current hospital guidelines under the care and surveillance of a pediatric emergency department registered nurse and physician Vital signs including heart rate blood pressure respiratory rate and oxygen saturation will be monitored continuously and recorded every 2 minutes with the exception of blood pressure which will be recorded every 4 minutes The assisting registered nurse will also record information regarding time of last liquid and solid intake and body weight on the hospitals standard procedural sedation and analgesia record form
A separate standardized datasheet Appendix B will be used to collect the time when the study drug was first administered the time when the procedure began the time the procedure was completed and the time to recovery Upon completion of the procedure a recovery score based on a modified Aldrete Scale will be recorded by a research associate blinded as to the intervention used every 2 minutes until full recovery defined as a minimum cumulative score of 8 The attending physician will be asked to document any complications including hypotension apnea hypoxia laryngospasm and pain on injection that occurred during the procedure and if any interventions were necessary The nurse caring for the patient will also record any adverse events nausea vomiting agitation that occurred during recovery
Outcome Measures The primary outcome will be total sedation time defined as the time that the first study drug was injected until the patient is fully recovered with a minimum recovery score 8 Secondary outcomes will include time to recovery patient nurse and physician satisfaction complications and adverse events The patient nurse and physician will be asked to individually assess their level of satisfaction with the sedation procedure using a 7-point Likert scale Appendices C-E
Analyses Strategy The independent samples t-test will be used to compare differences in mean total sedation time and recovery time between the Ketamine and Ketamine-Propofol groups The Mann-Whitney test will be used to compare differences in satisfaction levels measured on an ordinal scale between groups Differences in proportions of complications during the procedure and adverse events during recovery will be assessed by the Chi-Square test between groups A p value 005 will be considered statistically significant
Expectation The expectation of the study is paediatric emergency department patients requiring procedural sedation for an isolated orthopaedic injury with Ketamine-Propofol will have reduced total sedation time time to recovery complications and improved satisfaction scores compared to patients receiving Ketamine alone
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRF 044-06 | None | None | None |