The Ketamine for Acute Postoperative Analgesia (KAPA) Trial
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

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 1950's, 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 Hospital/UHN.
      Investigators expect the study to last for about 12 months.
    

Intervention name(s): Ketamine; Placebo
Intervention type(s): Drug; Other
Intervention description(s): The use of oral Ketamine in this study is experimental.This study will look at how effective and safe Ketamine.; A placebo is given in this study to reduce the chances of believing that pain after surgery is getting better because one is receiving oral Ketamine
Other intervention name(s): Ketamine Group; Placebo group
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study will be a two arm, randomized controlled trial with a target enrollment of forty patients. Randomization will be performed with a 1:1 allocation with Ketamine or Placebo.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postoperative; pain; effective; safe; Ketamine; placebo