Ignite Creation Date:
2024-05-06 @ 3:29 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04646694
Status:
COMPLETED
Last Update Posted:
2024-05-21
First Post:
2020-11-17
Brief Title:
The Ketamine for Acute Postoperative Analgesia KAPA Trial
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
The Ketamine for Acute Postoperative Analgesia KAPA Trial
Status:
COMPLETED
Status Verified Date:
2023-08
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:
KAPA
Brief Summary:
Postoperative pain remains an important challenge for both patients and clinicians Despite advances in pain management techniques many patients continue to describe their pain as moderate to severe immediately after surgery Poor postoperative pain control is associated with increased morbidity functional impairment and higher health care costs While opioids currently represent the mainstay of treating surgical pain their use is associated with significant side effects including respiratory depression delayed recovery of bowel function as well as the potential for long-term use Therefore there is an urgent need to find new pain relievers with a safer side effect profiles One such drug that has been receiving increasing attention is ketamine Previous studies have focused on using intravenous ketamine postoperatively which requires a monitored setting but have ignored the oral form By using the oral route of administration ketamine could potentially be used by patients in a less resource-intensive manner with similar efficacy Therefore Investigators propose to conduct the Ketamine for Acute Postoperative Analgesia KAPA pilot study to examine the role of oral ketamine in improving recovery after spine surgery
Detailed Description:
Pain after surgery remains an important challenge for both patients and clinicians Despite advances in pain management techniques many patients continue to describe their pain as moderate to severe immediately after surgery Poor surgical pain control is associated with increased morbidity functional impairment and higher health care costs While opioids currently represent the mainstay of treating surgical pain their use is associated with significant side effects including respiratory depression delayed recovery of bowel function as well as the potential for long-term use
Therefore there is an urgent need to find new pain relievers with a safer side effect profiles One such drug that has been receiving increasing attention is ketamine Previous studies have focused on using intravenous ketamine postoperatively which requires a monitored setting but have ignored the oral form By using the oral route of administration ketamine could potentially be used by patients in a less resource-intensive manner with similar efficacy Therefore Investigators propose to conduct the Ketamine for Acute Postoperative Analgesia KAPA pilot study to examine the role of oral ketamine in improving recovery after spine surgery
The drug being studied in this trial is called Ketamine Ketamine was initially developed as a unique anesthetic drug in the 1950s clinicians later realized that when given in low doses Ketamine can improve pain control after surgery and other chronic neuropathic conditions It can be particularly helpful for patients whose pain is not adequately controlled with commonly used pain medications Ketamine has also found new roles to aid in opioid tapering of subjects with opioid dependence and in the treatment of addiction
Health Canada has approved Ketamine for medical use in hospital setting as an IV anesthetic agent for surgical procedures However there are currently no Health Canada approved oral Ketamine formulations Although it should be noted that oral ketamine is routinely used as part of standard order sets at several health institutions across Toronto and Canada
The use of oral Ketamine in this study is experimental Experimental means Health Canada has not approved the oral use of Ketamine but they have approved its use in this research study
This study will look at how effective and safe Ketamine
If participant decide to participate the investigator will be in contact with your regular health care provider throughout the time that you are in the study and afterwards if needed
Participants are being asked to take part in this research study because they will be having elective spine surgery under general anesthesia and participants may develop pain after surgery
The usual treatment for established pain after surgery is an approved intravenous opioid such as hydromorphone acetaminophen and nonsteroidal anti-inflammatory drugs NSAIDs However opiates usage carries significant risk of addiction and overdose particularly with prolonged or increased dosing Using a combination of medications to treat postoperative pain is quickly becoming more common in an attempt to avoid severe post-operative pain Because of these limitations it is important that Investigators look for new options to treat surgical pain
Approximately 40 people will take part in this study at Toronto Western HospitalUHN Investigators expect the study to last for about 12 months
Therefore there is an urgent need to find new pain relievers with a safer side effect profiles One such drug that has been receiving increasing attention is ketamine Previous studies have focused on using intravenous ketamine postoperatively which requires a monitored setting but have ignored the oral form By using the oral route of administration ketamine could potentially be used by patients in a less resource-intensive manner with similar efficacy Therefore Investigators propose to conduct the Ketamine for Acute Postoperative Analgesia KAPA pilot study to examine the role of oral ketamine in improving recovery after spine surgery
The drug being studied in this trial is called Ketamine Ketamine was initially developed as a unique anesthetic drug in the 1950s clinicians later realized that when given in low doses Ketamine can improve pain control after surgery and other chronic neuropathic conditions It can be particularly helpful for patients whose pain is not adequately controlled with commonly used pain medications Ketamine has also found new roles to aid in opioid tapering of subjects with opioid dependence and in the treatment of addiction
Health Canada has approved Ketamine for medical use in hospital setting as an IV anesthetic agent for surgical procedures However there are currently no Health Canada approved oral Ketamine formulations Although it should be noted that oral ketamine is routinely used as part of standard order sets at several health institutions across Toronto and Canada
The use of oral Ketamine in this study is experimental Experimental means Health Canada has not approved the oral use of Ketamine but they have approved its use in this research study
This study will look at how effective and safe Ketamine
If participant decide to participate the investigator will be in contact with your regular health care provider throughout the time that you are in the study and afterwards if needed
Participants are being asked to take part in this research study because they will be having elective spine surgery under general anesthesia and participants may develop pain after surgery
The usual treatment for established pain after surgery is an approved intravenous opioid such as hydromorphone acetaminophen and nonsteroidal anti-inflammatory drugs NSAIDs However opiates usage carries significant risk of addiction and overdose particularly with prolonged or increased dosing Using a combination of medications to treat postoperative pain is quickly becoming more common in an attempt to avoid severe post-operative pain Because of these limitations it is important that Investigators look for new options to treat surgical pain
Approximately 40 people will take part in this study at Toronto Western HospitalUHN Investigators expect the study to last for about 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None