TY - JOUR
T1 - Perioperative use of etoricoxib reduces pain and opioid side-effects after total abdominal hysterectomy
T2 - a double-blind, randomized, placebo-controlled phase III study
AU - Viscusi, Eugene R
AU - Frenkl, Tara L
AU - Hartrick, Craig T
AU - Rawal, Narinder
AU - Kehlet, Henrik
AU - Papanicolaou, Dimitris
AU - Gammaitoni, Arnold
AU - Ko, Amy T
AU - Morgan, Leslie M
AU - Mehta, Anish
AU - Curtis, Sean P
AU - Peloso, Paul M
PY - 2012/8
Y1 - 2012/8
N2 - Objective: To evaluate the effects of two different doses of etoricoxib delivered perioperatively compared with placebo and standard pain management on pain at rest, pain with mobilization, and use of additional morphine/opioids postoperatively. Research design and methods: In this double-blind, placebo-controlled, randomized clinical trial, we evaluated postoperative pain following total abdominal hysterectomy over 5 days in patients receiving placebo or etoricoxib administered 90min prior to surgery and continuing postoperatively. Patients were randomly assigned to receive either placebo (n=144), etoricoxib90mg/day (n=142), or etoricoxib 120mg/day (n=144). Average Pain Intensity at Rest over days 1-3 (0-to 10-point numerical rating scale [NRS]) was the primary efficacy endpoint. Secondary endpoints included Average Pain Intensity upon Sitting, Standing, and Walking over days 1-3 (0-to 10-point NRS) as well as Average Total Daily Dose of Morphine over days 1-3. Clinical trial registration: This trial is registered on www.clinicaltrials.gov (NCT00788710). Results: The least squares (LS) means (95% CI) for the primary endpoint were 3.26 (2.96, 3.55); 2.46 (2.16, 2.76); and 2.40 (2.11, 2.69) for placebo, etoricoxib 90 mg, and etoricoxib 120mg, respectively, significantly different for both etoricoxib doses versus placebo (p<0.001). Patients on etoricoxib 90 mg and 120 mg required ∼30 less morphine per day than those on placebo (p<0.001), which led to more rapid bowel recovery in the active treatment groups by ∼10 hours vs. placebo. A greater proportion of patients on etoricoxib (1030 greater than placebo) achieved mild levels of pain with movement, defined as pain ≤3/10. Limitations: A key limitation for this study was that movement-evoked pain measurements were not designated as primary endpoints. Conclusion: In patients undergoing total abdominal hysterectomy, etoricoxib 90 mg and 120 mg dosed preoperatively and then continued postoperatively significantly reduces both resting and movement-related pain, as well as reduced opioid (morphine) consumption that led to more rapid bowel recovery.
AB - Objective: To evaluate the effects of two different doses of etoricoxib delivered perioperatively compared with placebo and standard pain management on pain at rest, pain with mobilization, and use of additional morphine/opioids postoperatively. Research design and methods: In this double-blind, placebo-controlled, randomized clinical trial, we evaluated postoperative pain following total abdominal hysterectomy over 5 days in patients receiving placebo or etoricoxib administered 90min prior to surgery and continuing postoperatively. Patients were randomly assigned to receive either placebo (n=144), etoricoxib90mg/day (n=142), or etoricoxib 120mg/day (n=144). Average Pain Intensity at Rest over days 1-3 (0-to 10-point numerical rating scale [NRS]) was the primary efficacy endpoint. Secondary endpoints included Average Pain Intensity upon Sitting, Standing, and Walking over days 1-3 (0-to 10-point NRS) as well as Average Total Daily Dose of Morphine over days 1-3. Clinical trial registration: This trial is registered on www.clinicaltrials.gov (NCT00788710). Results: The least squares (LS) means (95% CI) for the primary endpoint were 3.26 (2.96, 3.55); 2.46 (2.16, 2.76); and 2.40 (2.11, 2.69) for placebo, etoricoxib 90 mg, and etoricoxib 120mg, respectively, significantly different for both etoricoxib doses versus placebo (p<0.001). Patients on etoricoxib 90 mg and 120 mg required ∼30 less morphine per day than those on placebo (p<0.001), which led to more rapid bowel recovery in the active treatment groups by ∼10 hours vs. placebo. A greater proportion of patients on etoricoxib (1030 greater than placebo) achieved mild levels of pain with movement, defined as pain ≤3/10. Limitations: A key limitation for this study was that movement-evoked pain measurements were not designated as primary endpoints. Conclusion: In patients undergoing total abdominal hysterectomy, etoricoxib 90 mg and 120 mg dosed preoperatively and then continued postoperatively significantly reduces both resting and movement-related pain, as well as reduced opioid (morphine) consumption that led to more rapid bowel recovery.
U2 - 10.1185/03007995.2012.707121
DO - 10.1185/03007995.2012.707121
M3 - Journal article
C2 - 22738802
SN - 0141-9951
VL - 28
SP - 1323
EP - 1335
JO - Current Medical Research and Opinion, Supplement
JF - Current Medical Research and Opinion, Supplement
IS - 8
ER -