IADR Abstract Archives
Opioids’ Impact on Pain-Interference and Sleep: the OARS Pilot Study
Objectives: A pilot study was conducted examining sleep quality and pain interference with different analgesic combinations in preparation for a double-blind, randomized multi-site comparative effectiveness trial investigating the non-inferiority of a combination of ibuprofen 400 mg/paracetamol 500mg (NON-OPIOID) to the most commonly prescribed opioid containing analgesic in dentistry - hydrocodone 5mg/paracetamol 300 mg (OPIOID).
Methods: Patients undergoing impacted mandibular third molar surgery were recruited. Subjects were provided 20 doses of blinded study analgesic after surgery and unused study analgesic was collected at the post-operative visit for diversion. After an initial dose post-surgery, subjects were instructed to take their assigned analgesic as needed for pain. Subjects completed surveys prior to surgery and during their post-op examination visit. In addition, subjects submitted electronic pain diary entries each morning and each evening. In addition to pain levels, subjects were asked to evaluate sleep quality using the Pain and Sleep Quality 3 question index (PSQ-3) and pain interreference using the PROMIS Short 6b form. Data was captured in REDCap and analyzed in SAS using mixed model analysis.
Results: Fifty-three (53) subjects were randomly assigned with 50 ultimately receiving investigational product. NON-OPIOID had significantly better sleep quality than OPIOID at 24, 48, and 72 hours (3.76 vs. 5.45 p=0.023; 3.44 vs. 5.25 p=0.006; 3.36 vs. 4.91 p=0.011) on a 10pt numeric rating scale (0=excellent sleep and 10=poorest sleep). NON-OPIOID also had significantly lower pain-interference scores at 24, 48, and 72 hours (2.39 vs. 2.94 p=0.064, 2.25 vs. 2.70 p=0.046; 2.03 vs. 2.58 p=0.040) on a 5pt Likert scale (lower score = less interference in daily activities).
Conclusions: NON-OPIOID pain levels were significantly lower for all three time periods. These results suggest that in addition to better pain control, the combination of ibuprofen and paracetamol may result in patients experiencing better sleep, and less interference with normal daily activities.
Methods: Patients undergoing impacted mandibular third molar surgery were recruited. Subjects were provided 20 doses of blinded study analgesic after surgery and unused study analgesic was collected at the post-operative visit for diversion. After an initial dose post-surgery, subjects were instructed to take their assigned analgesic as needed for pain. Subjects completed surveys prior to surgery and during their post-op examination visit. In addition, subjects submitted electronic pain diary entries each morning and each evening. In addition to pain levels, subjects were asked to evaluate sleep quality using the Pain and Sleep Quality 3 question index (PSQ-3) and pain interreference using the PROMIS Short 6b form. Data was captured in REDCap and analyzed in SAS using mixed model analysis.
Results: Fifty-three (53) subjects were randomly assigned with 50 ultimately receiving investigational product. NON-OPIOID had significantly better sleep quality than OPIOID at 24, 48, and 72 hours (3.76 vs. 5.45 p=0.023; 3.44 vs. 5.25 p=0.006; 3.36 vs. 4.91 p=0.011) on a 10pt numeric rating scale (0=excellent sleep and 10=poorest sleep). NON-OPIOID also had significantly lower pain-interference scores at 24, 48, and 72 hours (2.39 vs. 2.94 p=0.064, 2.25 vs. 2.70 p=0.046; 2.03 vs. 2.58 p=0.040) on a 5pt Likert scale (lower score = less interference in daily activities).
Conclusions: NON-OPIOID pain levels were significantly lower for all three time periods. These results suggest that in addition to better pain control, the combination of ibuprofen and paracetamol may result in patients experiencing better sleep, and less interference with normal daily activities.