IADR Abstract Archives
Limitations of Opioids in Managing Pain: the OARS Pilot Study
Objectives: We conducted a pilot study in preparation for a double-blind, randomized multi-site comparative effectiveness trial examining the non-inferiority of combination ibuprofen 400 mg/paracetamol 500mg (NON-OPIOID) to the most commonly prescribed opioid analgesic, hydrocodone 5mg/paracetamol 300 mg (OPIOID).
Methods: Patients undergoing impacted mandibular third-molar surgery were provided 20 blinded doses of study analgesic after surgery and unused study analgesic was collected at the post-operative visit. After an initial dose post-surgery, subjects were instructed to take assigned analgesic as needed for pain. Subjects completed surveys prior to surgery and during their post operative examination visit. In addition, subjects completed electronic pain diary entries each morning upon waking and each evening prior to bed. Pain was assessed using the Brief Pain Inventory (BPI) which asks subjects to rate their average, least, worst and current pain levels on a scale of 0 to 10 (0=no pain, 10=worst pain) for each edairy entry. Data was captured in REDCap and analyzed in SAS using mixed model analysis.
Results: 53 subjects were randomly assigned with 50 ultimately receiving investigation product. There were statistically significant differences (P>0.05) in pain intensity. Subjects were 50% females, 26 % Hispanic, 34% African American and 14% Asian with a mean age of 24 years. Subjects reported their average pain levels for the first 24 hours, 48 hours and 72 hours of 5.67, 5.10 and 4.78 for OPIOID vs. 4.09, 3.57 and 3.32 for NON-OPIOID (P=0.009, 0.008, 0.010). Subjects reported worst pain levels as 6.95, 6.43 and 6.10 vs. 5.23, 4.78 and 4.46 (p=0.011, 0.009, 0.008).
Conclusions: NON-OPIOID pain levels were significantly lower for all three time periods. These results suggest that a combination of ibuprofen and paracetamol may be more effective in managing post-operative dental pain then opioid containing analgesics. Additional results on pain levels and use of the rescue analgesics will be presented.
Methods: Patients undergoing impacted mandibular third-molar surgery were provided 20 blinded doses of study analgesic after surgery and unused study analgesic was collected at the post-operative visit. After an initial dose post-surgery, subjects were instructed to take assigned analgesic as needed for pain. Subjects completed surveys prior to surgery and during their post operative examination visit. In addition, subjects completed electronic pain diary entries each morning upon waking and each evening prior to bed. Pain was assessed using the Brief Pain Inventory (BPI) which asks subjects to rate their average, least, worst and current pain levels on a scale of 0 to 10 (0=no pain, 10=worst pain) for each edairy entry. Data was captured in REDCap and analyzed in SAS using mixed model analysis.
Results: 53 subjects were randomly assigned with 50 ultimately receiving investigation product. There were statistically significant differences (P>0.05) in pain intensity. Subjects were 50% females, 26 % Hispanic, 34% African American and 14% Asian with a mean age of 24 years. Subjects reported their average pain levels for the first 24 hours, 48 hours and 72 hours of 5.67, 5.10 and 4.78 for OPIOID vs. 4.09, 3.57 and 3.32 for NON-OPIOID (P=0.009, 0.008, 0.010). Subjects reported worst pain levels as 6.95, 6.43 and 6.10 vs. 5.23, 4.78 and 4.46 (p=0.011, 0.009, 0.008).
Conclusions: NON-OPIOID pain levels were significantly lower for all three time periods. These results suggest that a combination of ibuprofen and paracetamol may be more effective in managing post-operative dental pain then opioid containing analgesics. Additional results on pain levels and use of the rescue analgesics will be presented.