Back to resultsPost-Operative Pain Control in Opioid Tolerant Patients: Fentanyl Challenge Protocol Versus Standard of Care
Primary Purpose
Pain, Postoperative
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Fentanyl
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative
Eligibility Criteria
Inclusion Criteria:
- Age > 18
- Anticipated need for PCA dosing post-operatively
- Will undergo major general, plastic, vascular, thoracic or spine surgery
- Have taken opioid medications orally or transdermally daily for the past 30 days
Exclusion Criteria:
- Patients assessed to have a difficult airway
- Known sensitivity or allergy to fentanyl
Sites / Locations
- Bassett Healthcare Network
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Fentanyl Challenge Dosing
Standard of Care (Control)
Arm Description
In the operating room a fentanyl infusion will be started at 2 mcg/kg/min. The time from start of the infusion to respiratory depression(rate < 5 breaths/minute) will be used to calculate the effect-site concentration (Ce).Using the pharmacodynamic model calculated by the Stanpump PCA software, the infusion will continue intraoperatively to achieve a fentanyl Ce of 30%. In the Post Anesthesia Care Unit (PACU), the rate would be changed with the following parameters: 50% of the hourly dose is given as a basal infusion The remainder of the hourly dose is ordered as a demand dose q 15 minutes. Post-operatively, the basal rate is adjusted according to the average demand dose use. In patients using < 1 demand dose per hour, the basal rate is decreased by 20%. In patients using > 3 demand doses per hour, the basal rate is increased by 20%. Patients whose pain cannot be managed by this protocol will be removed from the study and pain management will revert to the primary service.
Patients in the best practice arm would receive pre-operative sedation in the operating room comparable to the dose normally given in the Ambulatory Surgery Unit as a "simulated fentanyl challenge". Best practice (control) patients will be followed by the Pain & Palliative Care team in order to make adjustments in pain management as required by the patients.
Outcomes
Primary Outcome Measures
Pain Score
Patients will rate their pain on a scale of 1-10 (1 being best, 10 being worst)
Secondary Outcome Measures
Pain Score
Patients will rate their pain on a scale of 1-10 (1 being best, 10 being worst)
Events requiring intervention for respiratory depression
All adverse events will be documented including administration of naloxone, prompting to take more frequent breaths by staff and respiratory rate less than 8 per minute
Number of dose adjustments required
Study will record the number of dose adjustments required to maintain adequate pain control
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02324933
Brief Title
Post-Operative Pain Control in Opioid Tolerant Patients: Fentanyl Challenge Protocol Versus Standard of Care
Official Title
Post-Operative Pain Control in Opioid Tolerant Patients: Fentanyl Challenge Protocol Versus Standard of Care
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Withdrawn
Why Stopped
insufficient population, unable to recruit
Study Start Date
August 2014 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bassett Healthcare
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the value of dosing pain medications based upon a patient's pre-operative tolerance to pain medications. Study participants will be assigned to one of two groups, a treatment group and a control group. The treatment group will be given pain medications after surgery based upon their measured response to pain medications prior to surgery. The control group will be given pain medications based upon the normal dosing routine as is currently practiced. Both groups will be closely monitored for side effects and have their pain scores recorded for the first 48 hours following surgery.
Detailed Description
This study will focus on patients who are opioid-tolerant pre-operatively, a patient population which typically has both higher pain scores and more complications related to analgesics than opioid naïve patients. Currently, there is no standardized system for determining an adequate pain control regimen for a patient post-operatively. At this institution, pain medications are dosed per physician preference. The most widely-discussed method for calculating tolerance to opioids relies on converting a patient's daily opioid consumption to a morphine equivalent dose and basing a pain regimen upon that number. This method does not account for variability of response to different medications or dosing forms however. It would be advantageous to have a method of dosing opioid pain medications in this population that is both safe and effective.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fentanyl Challenge Dosing
Arm Type
Experimental
Arm Description
In the operating room a fentanyl infusion will be started at 2 mcg/kg/min. The time from start of the infusion to respiratory depression(rate < 5 breaths/minute) will be used to calculate the effect-site concentration (Ce).Using the pharmacodynamic model calculated by the Stanpump PCA software, the infusion will continue intraoperatively to achieve a fentanyl Ce of 30%. In the Post Anesthesia Care Unit (PACU), the rate would be changed with the following parameters:
50% of the hourly dose is given as a basal infusion
The remainder of the hourly dose is ordered as a demand dose q 15 minutes. Post-operatively, the basal rate is adjusted according to the average demand dose use. In patients using < 1 demand dose per hour, the basal rate is decreased by 20%. In patients using > 3 demand doses per hour, the basal rate is increased by 20%. Patients whose pain cannot be managed by this protocol will be removed from the study and pain management will revert to the primary service.
Arm Title
Standard of Care (Control)
Arm Type
Active Comparator
Arm Description
Patients in the best practice arm would receive pre-operative sedation in the operating room comparable to the dose normally given in the Ambulatory Surgery Unit as a "simulated fentanyl challenge". Best practice (control) patients will be followed by the Pain & Palliative Care team in order to make adjustments in pain management as required by the patients.
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Other Intervention Name(s)
Versed
Intervention Description
Fentanyl Patient Controlled Analgesia for post-operative pain management
Primary Outcome Measure Information:
Title
Pain Score
Description
Patients will rate their pain on a scale of 1-10 (1 being best, 10 being worst)
Time Frame
48 hours post-operatively
Secondary Outcome Measure Information:
Title
Pain Score
Description
Patients will rate their pain on a scale of 1-10 (1 being best, 10 being worst)
Time Frame
24 hours post-operatively
Title
Events requiring intervention for respiratory depression
Description
All adverse events will be documented including administration of naloxone, prompting to take more frequent breaths by staff and respiratory rate less than 8 per minute
Time Frame
48 hours post-operatively
Title
Number of dose adjustments required
Description
Study will record the number of dose adjustments required to maintain adequate pain control
Time Frame
48 hours post-operatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 18
Anticipated need for PCA dosing post-operatively
Will undergo major general, plastic, vascular, thoracic or spine surgery
Have taken opioid medications orally or transdermally daily for the past 30 days
Exclusion Criteria:
Patients assessed to have a difficult airway
Known sensitivity or allergy to fentanyl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jose Monzon, MD
Organizational Affiliation
Bassett Healthcare
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bassett Healthcare Network
City
Cooperstown
State/Province
New York
ZIP/Postal Code
13326
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16037150
Citation
Davis JJ, Swenson JD, Hall RH, Dillon JD, Johnson KB, Egan TD, Pace NL, Niu SY. Preoperative "fentanyl challenge" as a tool to estimate postoperative opioid dosing in chronic opioid-consuming patients. Anesth Analg. 2005 Aug;101(2):389-395. doi: 10.1213/01.ANE.0000156563.25878.19. Erratum In: Anesth Analg. 2005 Oct;101(4):965.
Results Reference
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Post-Operative Pain Control in Opioid Tolerant Patients: Fentanyl Challenge Protocol Versus Standard of Care
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