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Presurgical intravenous parecoxib sodium and follow-up oral valdecoxib for pain management after laparoscopic cholecystectomy surgery reduces opioid requirements and opioid-related adverse effects.
Acta Anaesthesiol Scand. 2004 Oct; 48(9):1194-207.AA

Abstract

BACKGROUND

Opioids are associated with numerous adverse effects. It is unclear if reduced postoperative opioid consumption lowers the incidence and severity of opioid-related adverse effects. This analysis -- from a multicenter, randomized, double-blind trial -- tested if the reduction of opioid consumption among patients who received intravenous preoperative parecoxib 40 mg, followed by oral valdecoxib 40 mg qd postoperatively, in Days 1-4 after outpatient laparoscopic cholecystectomy surgery, reduced opioid-related symptoms.

METHODS

Patients received intravenous fentanyl for pain before discharge, and oral acetaminophen 500 mg hydrocodone 5 mg q 4-6 h prn postdischarge for up to 7 days postsurgery. Patients also received intravenous parecoxib 40 mg administered 30-45 min preoperatively, and valdecoxib 40 mg qd up to Day 4 and prn Days 5-7 postsurgery, or placebo. Patients completed an opioid-related Symptoms Distress Scale (SDS) questionnaire every 24 h for 7 days. Opioid use was converted to morphine-equivalent doses (MEDs). Clinically meaningful events (CMEs) for 12 opioid-related symptoms were assessed by three ordinal measures: frequency, severity, and bothersomeness. Reduction of CMEs on Day 1 and number of patient-days with CMEs on Days 1-4 were examined.

RESULTS

Cumulative MEDs on Day 0, Day 1, and Days 1-4 were significantly lower in the parecoxib/valdecoxib group compared with the placebo group (P < 0.001). At the end of Day 1, parecoxib/valdecoxib-treated patients had significantly lower SDS scores (P < 0.02), a significantly reduced incidence of CMEs (P < 0.05), and significantly fewer patient-days with CMEs in Days 1-4 than placebo patients (P < 0.05). Patients in the parecoxib/valdecoxib group were less likely to have CMEs for multiple symptoms than those in the placebo group (P < 0.001).

CONCLUSIONS

Treatment with parecoxib and valdecoxib significantly reduced the cumulative MED requirements, the incidence of opioid-related adverse effects, and patient-days with CMEs.

Authors+Show Affiliations

Department of Anesthesiology, Duke University Medical Center, Durham, NC 27710, USA. gan00001@mcduke.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

15352969

Citation

Gan, T J., et al. "Presurgical Intravenous Parecoxib Sodium and Follow-up Oral Valdecoxib for Pain Management After Laparoscopic Cholecystectomy Surgery Reduces Opioid Requirements and Opioid-related Adverse Effects." Acta Anaesthesiologica Scandinavica, vol. 48, no. 9, 2004, pp. 1194-207.
Gan TJ, Joshi GP, Zhao SZ, et al. Presurgical intravenous parecoxib sodium and follow-up oral valdecoxib for pain management after laparoscopic cholecystectomy surgery reduces opioid requirements and opioid-related adverse effects. Acta Anaesthesiol Scand. 2004;48(9):1194-207.
Gan, T. J., Joshi, G. P., Zhao, S. Z., Hanna, D. B., Cheung, R. Y., & Chen, C. (2004). Presurgical intravenous parecoxib sodium and follow-up oral valdecoxib for pain management after laparoscopic cholecystectomy surgery reduces opioid requirements and opioid-related adverse effects. Acta Anaesthesiologica Scandinavica, 48(9), 1194-207.
Gan TJ, et al. Presurgical Intravenous Parecoxib Sodium and Follow-up Oral Valdecoxib for Pain Management After Laparoscopic Cholecystectomy Surgery Reduces Opioid Requirements and Opioid-related Adverse Effects. Acta Anaesthesiol Scand. 2004;48(9):1194-207. PubMed PMID: 15352969.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Presurgical intravenous parecoxib sodium and follow-up oral valdecoxib for pain management after laparoscopic cholecystectomy surgery reduces opioid requirements and opioid-related adverse effects. AU - Gan,T J, AU - Joshi,G P, AU - Zhao,S Z, AU - Hanna,D B, AU - Cheung,R Y, AU - Chen,C, PY - 2004/9/9/pubmed PY - 2004/12/23/medline PY - 2004/9/9/entrez SP - 1194 EP - 207 JF - Acta anaesthesiologica Scandinavica JO - Acta Anaesthesiol Scand VL - 48 IS - 9 N2 - BACKGROUND: Opioids are associated with numerous adverse effects. It is unclear if reduced postoperative opioid consumption lowers the incidence and severity of opioid-related adverse effects. This analysis -- from a multicenter, randomized, double-blind trial -- tested if the reduction of opioid consumption among patients who received intravenous preoperative parecoxib 40 mg, followed by oral valdecoxib 40 mg qd postoperatively, in Days 1-4 after outpatient laparoscopic cholecystectomy surgery, reduced opioid-related symptoms. METHODS: Patients received intravenous fentanyl for pain before discharge, and oral acetaminophen 500 mg hydrocodone 5 mg q 4-6 h prn postdischarge for up to 7 days postsurgery. Patients also received intravenous parecoxib 40 mg administered 30-45 min preoperatively, and valdecoxib 40 mg qd up to Day 4 and prn Days 5-7 postsurgery, or placebo. Patients completed an opioid-related Symptoms Distress Scale (SDS) questionnaire every 24 h for 7 days. Opioid use was converted to morphine-equivalent doses (MEDs). Clinically meaningful events (CMEs) for 12 opioid-related symptoms were assessed by three ordinal measures: frequency, severity, and bothersomeness. Reduction of CMEs on Day 1 and number of patient-days with CMEs on Days 1-4 were examined. RESULTS: Cumulative MEDs on Day 0, Day 1, and Days 1-4 were significantly lower in the parecoxib/valdecoxib group compared with the placebo group (P < 0.001). At the end of Day 1, parecoxib/valdecoxib-treated patients had significantly lower SDS scores (P < 0.02), a significantly reduced incidence of CMEs (P < 0.05), and significantly fewer patient-days with CMEs in Days 1-4 than placebo patients (P < 0.05). Patients in the parecoxib/valdecoxib group were less likely to have CMEs for multiple symptoms than those in the placebo group (P < 0.001). CONCLUSIONS: Treatment with parecoxib and valdecoxib significantly reduced the cumulative MED requirements, the incidence of opioid-related adverse effects, and patient-days with CMEs. SN - 0001-5172 UR - https://www.unboundmedicine.com/medline/citation/15352969/Presurgical_intravenous_parecoxib_sodium_and_follow_up_oral_valdecoxib_for_pain_management_after_laparoscopic_cholecystectomy_surgery_reduces_opioid_requirements_and_opioid_related_adverse_effects_ L2 - https://doi.org/10.1111/j.1399-6576.2004.00495.x DB - PRIME DP - Unbound Medicine ER -