(417) Opioid-Induced Nausea and Vomiting (OINV) in patients without immediate post-op nausea/vomiting

Abstract

Most post-op patients are discharged from surgical facilities without reports of nausea or vomiting. How many of these patients develop nausea/vomiting only after exposure to an opioid analgesic (ie, without contributing peri-operative factors)? We examined the frequency of OINV in these patients. Approximately 3 hours after surgical removal of third molar teeth, patients who had moderate/severe pain (on a categorical pain intensity scale, PI-CAT) were queried about nausea on a 0-10 Nausea Intensity Scale (NIS) and about vomiting on an ordinal Vomiting Frequency Scale (VFS). There were 187 (40%) of 466 patients who reported nausea/vomiting after surgery (but before treatment), 279 patients who had no prior nausea or vomiting at baseline. Qualifying patients without postoperative nausea/vomiting were randomized under double-blind conditions to hydrocodone 7.5 mg/acetaminophen 325 mg (HC/APAP, n=126), CL-108 (HC 7.5 mg/APAP 325 mg with promethazine 12.5 mg, n=128), or placebo (n=25). They self-dosed every 4-6 hours as needed for pain and used the PI-CAT, NIS and VFS at regular intervals. CL-108 and HC/APAP were demonstrated to be effective analgesics compared to placebo (both p<0.001). Moderate or severe nausea and single-episode or repeat vomiting occurred in 49% and 36% of patients treated with HC/APAP over the initial 48 post-op hours (when most patients treated pain). These outcomes were significantly reduced for patients who used CL-108 (29% and 18%, both p = 0.001), representing a 50% relative reduction in the risk of vomiting. These findings indicate that 36-49% of oral surgery patients without immediate post-op nausea/vomiting proceed to develop OINV and that CL-108 is an effective analgesic/anti-emetic for them. These results also have implications for the interpretation of AEs in post-operative trials in general: it is critical to measure pre-treatment nausea/vomiting in order to precisely report nausea/vomiting directly attributable to opioid treatment. Supported by a grant from Charleston Laboratories. Most post-op patients are discharged from surgical facilities without reports of nausea or vomiting. How many of these patients develop nausea/vomiting only after exposure to an opioid analgesic (ie, without contributing peri-operative factors)? We examined the frequency of OINV in these patients. Approximately 3 hours after surgical removal of third molar teeth, patients who had moderate/severe pain (on a categorical pain intensity scale, PI-CAT) were queried about nausea on a 0-10 Nausea Intensity Scale (NIS) and about vomiting on an ordinal Vomiting Frequency Scale (VFS). There were 187 (40%) of 466 patients who reported nausea/vomiting after surgery (but before treatment), 279 patients who had no prior nausea or vomiting at baseline. Qualifying patients without postoperative nausea/vomiting were randomized under double-blind conditions to hydrocodone 7.5 mg/acetaminophen 325 mg (HC/APAP, n=126), CL-108 (HC 7.5 mg/APAP 325 mg with promethazine 12.5 mg, n=128), or placebo (n=25). They self-dosed every 4-6 hours as needed for pain and used the PI-CAT, NIS and VFS at regular intervals. CL-108 and HC/APAP were demonstrated to be effective analgesics compared to placebo (both p<0.001). Moderate or severe nausea and single-episode or repeat vomiting occurred in 49% and 36% of patients treated with HC/APAP over the initial 48 post-op hours (when most patients treated pain). These outcomes were significantly reduced for patients who used CL-108 (29% and 18%, both p = 0.001), representing a 50% relative reduction in the risk of vomiting. These findings indicate that 36-49% of oral surgery patients without immediate post-op nausea/vomiting proceed to develop OINV and that CL-108 is an effective analgesic/anti-emetic for them. These results also have implications for the interpretation of AEs in post-operative trials in general: it is critical to measure pre-treatment nausea/vomiting in order to precisely report nausea/vomiting directly attributable to opioid treatment. Supported by a grant from Charleston Laboratories.