Post-Operative Pain Control in Opioid Tolerant Patients: Fentanyl Challenge Protocol Versus Standard of Care

Pain, Postoperative Clinical Trial

Official title:

Post-Operative Pain Control in Opioid Tolerant Patients: Fentanyl Challenge Protocol Versus Standard of Care

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02324933
• Other study ID #: 1064
• Status: Withdrawn
• Phase: Phase 4
• First received: December 19, 2014
• Last updated: October 30, 2015
• Start date: August 2014

Study information

• Verified date: October 2015
• Source: Bassett Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age > 18

2. Anticipated need for PCA dosing post-operatively

3. Will undergo major general, plastic, vascular, thoracic or spine surgery

4. Have taken opioid medications orally or transdermally daily for the past 30 days

Exclusion Criteria:

1. Patients assessed to have a difficult airway

2. Known sensitivity or allergy to fentanyl

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Fentanyl
Fentanyl Patient Controlled Analgesia for post-operative pain management

Locations

Country	Name	City	State
United States	Bassett Healthcare Network	Cooperstown	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bassett Healthcare

Country where clinical trial is conducted

United States, 

References & Publications (1)

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):389-95, table of contents. Erratum in: Anesth Analg. 2005 Oct;101(4):965. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Score	Patients will rate their pain on a scale of 1-10 (1 being best, 10 being worst)	48 hours post-operatively	No
Secondary	Pain Score	Patients will rate their pain on a scale of 1-10 (1 being best, 10 being worst)	24 hours post-operatively	No
Secondary	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	48 hours post-operatively	Yes
Secondary	Number of dose adjustments required	Study will record the number of dose adjustments required to maintain adequate pain control	48 hours post-operatively	No