Ketamine in Colorectal Surgery

NCT02785003 | Withdrawn Phase 4

• 1 other identifier: PRO00027024
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the effectiveness of ketamine infusions in the management of acute pain following open or laparoscopic colorectal surgery cases. Half of patients will receive the institutional standard of care and a placebo infusion (no active medication). The other half of patients will receive the institutional standard of care and a ketamine infusion. All subjects and staff will be blinded as to whether they are receiving placebo or ketamine.

Conditions

Acute Pain; Pain, Postoperative; Colorectal Surgery

Keywords

Colorectal Surgery; Acute Pain; Pain; post-operative pain; ketamine

Outcome Measures

Primary Outcomes (1)

• Inpatient opiate consumption standardized to oral morphine equivalents.

  Standardized to oral morphine equivalents

  1st 48 hours post-infusion initiation

Secondary Outcomes (9)

• Inpatient Opioid consumption standardized to oral morphine equivalents.

  Duration of Hospitalization. Typical hospital duration for this patient population is 3-5 days.

• Opioid consumption standardized to oral morphine equivalents.

  The 24-hours prior to leaving the hospital.

• AUCpain

  12-24 hours post infusion initiation

• AUCpain

  24-48 hours post-infusion initiation

• AUCpain

  6-12 hours post-infusion initiation

Study Arms (2)

Ketamine Infusion

EXPERIMENTAL

All infusion rates will be calculated based on ideal body weight. Patients will receive a bolus of the ketamine solution at a calculated dose of 0.25 mg/kg. A continuous infusion of ketamine will immediately follow at a rate of 2 mcg/kg/min. The continuous infusion to run for a duration of 48-hours.

Drug: Ketamine; Drug: Acetaminophen; Drug: Opioid; Drug: Alvimopan

Saline Placebo

PLACEBO COMPARATOR

All infusion rates will be calculated based on ideal body weight. Patients will receive a bolus of the saline solution at a calculated dose of 0.25 mg/kg. A continuous infusion of saline will immediately follow at a rate of 2 mcg/kg/min. The continuous infusion to run for a duration of 48-hours.

Drug: Placebo; Drug: Acetaminophen; Drug: Opioid; Drug: Alvimopan

Interventions

Placebo DRUG

Individuals enrolled into the control arm of the trial will receive a normal saline placebo infusion at a rate equivalent to the dosage of ketamine in the experimental arm.

Also known as: NaCl Placebo Solution

Saline Placebo

Ketamine DRUG

All individuals randomized to the experimental arm of the trial will receive ketamine therapy at a rate of 2 mcg/kg/hr dosed based on ideal body weight.

Ketamine Infusion

Acetaminophen DRUG

All patients admitted to the hospital will be placed on scheduled acetaminophen 1000mg PO q 6 hours unless signs of liver disease/impairment or creatinine clearance \< 35ml/min at which point dosage would be reduced to 650mg q 8 hours. Individuals unable to take oral medications would be placed on intravenous acetaminophen.

Also known as: Tylenol

Ketamine Infusion; Saline Placebo

Opioid DRUG

All individuals will receive as needed opiate therapy as an adjunct to the scheduled medications and "ketamine/placebo" solution. Choice in opiate therapy will be at the discretion of the attending faculty. Dosage and adjustments will be in accordance with the institutional policy on appropriate opiate dosage adjustment.

Also known as: Opiate, Narcotic, Morphine, Dilaudid

Ketamine Infusion; Saline Placebo

Alvimopan DRUG

All patients enrolled into the trial will be screened for eligibility for alvimopan utilization. Only in circumstances where patients are not on outpatient opioid medications and where they have not received any at time of arrival will alvimopan be administered. It will be given at least 30 minutes prior to surgery.

Also known as: Entereg

Ketamine Infusion; Saline Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than 18 years
• Surgical intervention required for the management of colonic disease
• Admission to either the acute care surgery or colorectal surgery service with an anticipated inpatient hospital stay of 72 hours.

You may not qualify if:

• History of adverse reaction to ketamine
• Chronic opioid therapy for \>3 weeks of \>30mg oral morphine equivalents per day
• Known substance abuse with prescription opioids or heroin
• Anticipated post-operative intubation (\>6hr duration)
• History of psychosis
• Active delirium
• Glaucoma
• Active acute coronary syndrome
• Severe, poorly controlled hypertension (systolic blood pressure \> 180)
• Concurrent use of monoamine oxidase inhibitors (MAOIs)
• Pregnancy
• Prisoners

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert Memorial Lutheran Hospital

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Acute Pain; Pain, Postoperative; Pain

Interventions

Ketamine; Acetaminophen; Analgesics, Opioid; Opiate Alkaloids; Narcotics; Morphine; Hydromorphone; alvimopan

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Alkaloids; Heterocyclic Compounds; Morphine Derivatives; Morphinans; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Thomas W Carver, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

• Carrie Y Peterson, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2016
• First Posted: May 27, 2016
• Study Start: July 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2018
• Last Updated: October 26, 2017

Record last verified: 2016-05

Locations

US (1)