PURPOSE: This study evaluated the safety and efficacy of increasing doses of intranasal butorphanol (Stadol NS, Bristol-Myers Squibb, New York, NY) compared with placebo in controlling moderate to severe pain after removal of bony impacted third molars. PATIENTS AND METHODS: This single-dose, double-blind, parallel-group, dose-response trial compared the efficacy and safety of 4 doses of intranasally administered butorphanol tartrate and placebo in controlling moderate to severe pain after the removal of impacted third molars in 151 patients. The study was conducted at 2 sites. The patients were randomly assigned to receive 1 dose of butorphanol tartrate: 0.25 mg (n = 31), 0.5 mg (n = 29), 1.0 mg (n = 30), 2.0 mg (n = 30), or placebo (n = 31). Medication was administered with a metered-dose spray pump. Patients rated pain intensity (PI), pain relief (PAR), pain half gone (PHG), and adverse events at 0.25, 0.5, 1, 2, 3, 4, 5, and 6 hours after treatment. At the end of the study period or before rescue medication (ibuprofen, 400 mg, or acetaminophen, 1,000 mg), patients provided an overall assessment (GLOBAL). RESULTS: A linear dose-response regression (P < or = .05) was observed for the means of pain intensity difference (PID), PAR, and PHG at 0.25, 0.5, and 1 hour, and for sum of pain intensity differences (SPID), sum of pain relief (TOTPAR), peak PID and PAR, and GLOBAL evaluation. The 1.0- and 2.0-mg groups experienced greater pain relief compared with placebo (P = .05) during the first hour after drug administration. The 1.0- and 2.0-mg groups had significantly better GLOBAL evaluations than the placebo group, but were not significantly different from placebo for time until remedication (TREMED). Incidence and severity of the most common adverse events were dose-related. Two severe adverse events (drowsiness and dizziness) occurred after the 2.0-mg dose. CONCLUSION:Intranasal butorphanol effectively relieved postsurgical dental pain, with a rapid onset within 15 minutes, and seems to be a promising addition to the current armamentarium of opioid analgesics. As with other opioids, it should be used cautiously in an outpatient setting.
RCT Entities:
PURPOSE: This study evaluated the safety and efficacy of increasing doses of intranasal butorphanol (Stadol NS, Bristol-Myers Squibb, New York, NY) compared with placebo in controlling moderate to severe pain after removal of bony impacted third molars. PATIENTS AND METHODS: This single-dose, double-blind, parallel-group, dose-response trial compared the efficacy and safety of 4 doses of intranasally administered butorphanol tartrate and placebo in controlling moderate to severe pain after the removal of impacted third molars in 151 patients. The study was conducted at 2 sites. The patients were randomly assigned to receive 1 dose of butorphanol tartrate: 0.25 mg (n = 31), 0.5 mg (n = 29), 1.0 mg (n = 30), 2.0 mg (n = 30), or placebo (n = 31). Medication was administered with a metered-dose spray pump. Patients rated pain intensity (PI), pain relief (PAR), pain half gone (PHG), and adverse events at 0.25, 0.5, 1, 2, 3, 4, 5, and 6 hours after treatment. At the end of the study period or before rescue medication (ibuprofen, 400 mg, or acetaminophen, 1,000 mg), patients provided an overall assessment (GLOBAL). RESULTS: A linear dose-response regression (P < or = .05) was observed for the means of pain intensity difference (PID), PAR, and PHG at 0.25, 0.5, and 1 hour, and for sum of pain intensity differences (SPID), sum of pain relief (TOTPAR), peak PID and PAR, and GLOBAL evaluation. The 1.0- and 2.0-mg groups experienced greater pain relief compared with placebo (P = .05) during the first hour after drug administration. The 1.0- and 2.0-mg groups had significantly better GLOBAL evaluations than the placebo group, but were not significantly different from placebo for time until remedication (TREMED). Incidence and severity of the most common adverse events were dose-related. Two severe adverse events (drowsiness and dizziness) occurred after the 2.0-mg dose. CONCLUSION: Intranasal butorphanol effectively relieved postsurgical dental pain, with a rapid onset within 15 minutes, and seems to be a promising addition to the current armamentarium of opioid analgesics. As with other opioids, it should be used cautiously in an outpatient setting.
Authors: Joshua B Radke; Kelly P Owen; Mark E Sutter; Jonathan B Ford; Timothy E Albertson Journal: Clin Rev Allergy Immunol Date: 2014-02 Impact factor: 8.667