Parecoxib relieves pain and has an opioid-sparing effect following major gastrointestinal surgery

Figures & data

Table 1 Parecoxib/valdecoxib dosing regimen

Day	Treatment
1 (Day of surgery after recovery from anesthesia)	Single 40 mg IV dose of parecoxib
1–3	20 mg IV or IM doses of parecoxib every 12 hours
4–10*	20 mg oral doses of valdecoxib every 12 hours

Note:

* Patients underwent transition from IV/IM parecoxib to oral valdecoxib once they could tolerate oral medication, but no sooner than Day 4.

Abbreviations: IM, intramuscular; IV, intravenous.

Table 2 Patient demographics

Characteristic	Placebo (n=126)	Parecoxib (n=111)
Gender, n (%)
Male	67 (53.2)	61 (55.0)
Female	59 (46.8)	50 (45.0)
Age, years
Mean (SD)	53.8 (15.8)	55.4 (14.9)
Median	56.3	56.8
Race, n (%)
White	121 (96.0)	109 (98.2)
Black	1 (0.8)	1 (0.9)
Asian	1 (0.8)	0 (0.0)
Not listed	3 (2.4)	1 (0.9)
BMI, kg/m^2
Mean (SD)	26.0 (4.4)	25.5 (4.1)
Median	25.34	25.7
Procedure type, na
Large intestine/rectum	41	41
Gall bladder	31	27
Gastric	17	13
Small intestine	8	10
Appendix	6	3
Pancreatic	3	4
Spleen	2	1
Esophageal	1	1
Other	23	24

Note:

a Patients could have had more than one procedure type, which is why numbers in this column add up to more than the total number of patients.

Abbreviation: BMI, body mass index.

Figure 1 Mean (SD) SPI-24 scores on Days 2 and 3 following surgery.

Note: *p<0.001 versus placebo.
Abbreviation: SPI-24, summed pain intensity over the previous 24 hours.

Figure 2 Mean (SD) mBPI-sf composite pain interference with function scores on Days 2 and 3 following surgery.

Note: *p<0.001 versus placebo.
Abbreviation: mBPI-sf, modified Brief Pain Inventory-short form.

Figure 3 Cumulative morphine consumption at 24, 48, and 72 hours post-initial dose of study medication.

Note: *p<0.001 versus placebo.

Figure 4 Risk of opioid-related symptoms on Day 2 following surgery.

Notes: Relative risk (parecoxib versus placebo) is shown in the graph. *p<0.05 versus placebo.

Figure 5 Patient (A) and Physician (B) Global Evaluation of Study Medication scores.

Notes: The number of patients and physicians included in this analysis was 223 (placebo=117; parecoxib=105) and 224 (placebo=118; parecoxib=106), respectively.

Table S1 List of institutional review board or ethics committees approving the study

Country	Institutional review board or ethics committee
USA	Baylor University Medical Center Institutional Review Board, Dallas, TX
	Lutheran Hospital IRB, Cleveland, OH
	Thomas Jefferson University Institutional Review Board, Philadelphia, PA
	Lehigh Valley Hospital Institutional Review Board, Allentown, PA
	University of New Mexico Health Sciences Center Human Research Review Committee, Albuquerque, NM
	Palmetto Health Alliance, Institutional Review Board, Columbia, SC
	Medical Center East Human Research Review Board, Birmingham, AL
	Biomedical Research Institute of America, San Diego, CA
	St Joseph’s Mercy Health Center, Hot Springs, AR
	University of Pennsylvania Office of Regulatory Affairs, Philadelphia, PA
	Forsyth Institutional Review Board, Winston-Salem, NC
	Huntington Memorial Hospital, Pasadena, CA
	Biomedical Research Alliance of New York, LLC Institutional Review Board, Great Neck, NY
	Florida Hospital Institutional Review Board, Orlando, FL
	CPHS Memorial Hermann Memorial City Medical Center, Houston, TX
	Medical Institutional Review Board, University of Kentucky, Lexington, KY
	Tucson Medical Center Human Research Committee, Tucson, AZ
	UCLA Office for Protection of Research Subjects IRB, Los Angeles, CA
	Committee for the Protection of Human Subjects, University of Texas Health Science Center, Houston, TX
	University of Miami Institutional Review Board, Miami, FL
	University of Pittsburgh Institutional Review Board, Pittsburgh, PA
	Magee Womens IRB, Pittsburgh, PA
	Maricopa Integrated Health System Institutional Review Board, Phoenix, AZ
	University of Wisconsin-Madison Health Sciences Human Subjects Committee, Madison, WI
	Sharp Healthcare, San Diego, CA
	University of Virginia Human Investigation Committee, Charlottesville, VA
	St John’s Institutional Review Board, Springfield, MO
	CareAlliance Health Services IRB, Charleston, SC
	Memorial Health Services Research Council, Long Beach, CA
	Office of Human Research Protection Institutional Review Board, Sacramento, CA
	Morristown Memorial Hospital Institutional Review Board, Morristown, NJ
	Baptist Health Medical Center Institutional Review Board, Little Rock, AR
	Medstar Research Institute Institutional Review Board, Hyattsville, MD
	Century City Hospital Laboratory, Los Angeles, CA
	BUMC IRB for Human Research, Boston, MA
	Northwestern University IRB, Chicago, IL
	Springfield Committee for Research Involving Human Subjects, Springfield, IL
	Aurora Health Care IRB, Milwaukee, WI
	Rush Presbyterian St Luke’s Medical Center, Chicago, IL
	Institutional Review Board Health Sciences Section, UMC, Columbia, MO
	Institutional Review Board of Christiana Corporation, Newark, DE
	DeKalb Medical Center IRB, Decatur, GA
	University of Texas Southwestern Medical Center at Dallas IRB, Dallas, TX
	University of Medicine and Dentistry of New Jersey, Robert Wood Johnson University Hospital Institutional Review Board, New Brunswick, NJ
	Human Subjects Committee, University of Kansas Medical Center, Kansas City, KS
	Mary Washington Hospital Institutional Review Board, Fredericksburg, VA
	Human Studies Committees University of Louisville, Louisville, KY
	Review Committee for Research Projects Involving Human Subjects, Institutional Review Board of Mary Imogene Bassett Hospital, Cooperstown, NY
	Eastern Virginia Medical School Institutional Review Board, Norfolk, VA
	Human Investigation Committee, Yale University, New Haven, CT
	University of Texas Medical Branch Institutional Review Board, Galveston, TX
	Galesburg Cottage Hospital IRB, Galesburg, IL
	Sacred Heart Hospital Clinical Investigative Board, Pensacola, FL
	University of North Texas Health Science Center at Fort Worth IRB, Fort Worth, TX
	Texas Tech University Health Sciences Center School of Medicine, Lubbock, TX
	Human Research Review Board, Baptist Health System, Inc., Birmingham, AL
	Institutional Review Committee Cooper Hospital/University Medical Center, Camden, NJ
	VA North Texas Healthcare System, Dallas TX
Argentina	Comite Independiente de Etica, Primera Catedra de Farmacologia, Facultad de Medicina, UBA, Buenos Aires
	Comite Independiente de Etica, para Ensayos en Farmacologia Clinica, Primera Catedra de Farmacologia Facultad de Medicina, UBA, Buenos Aires
	Comite Independiente de Etica para ensayos en Farmacologia Clinica Fundacion de Estudios Famacologicos y de Medicamentos, Buenos Aires
	Comite de Bioetica Hospital Municipal Bernadino, Buenos Aires
	Comite de Docencia e Investigacion Hospital Municipal Bernadino, Buenos Aires
	Comite de Docenceia e Investigacion del Hospital Aleman, Buenos Aires
	Comite de Docencia e Investigacion Instituto Alexander Fleming, Buenos Aires
	Comite de Bioetica Hospital de Agudos Dr Cosme Argerich, Buenos Aires
	Comite de Docencia de Investigacion Hospital de Agudos Dr Cosme Argerich
	Comite de Docencia e Investigacion Hospital Interzonal General de Agudos “Presidente Peron”, Buenos Aires
Chile	Comite Independiente de Etica del Hospital Dipreca, Las Condes, Santiago
	Comite de Etica Clinica Santa Maria, Providencia, Santiago
	Comite de Etica Mutual de Seguridad C.CH.C, Santiago
	Comite de Etica Escuela de Medicina Pontificia, Universidad Catolica de Chile, Santiago
	Comite de Etica Hospital Clinico, Universidad de Chile, Santiago
Israel	Kaplan Medical Center Ethics Committee, Rehovot
	Rabin MC Ethics Committee, Petah Tikva
	Sapir MC Ethics Committee, Sapir MC/Meir Hospital, Kfar Saba
	Sourasky MC Ethics Committee, Tel Aviv
Canada	Comite d’ethique de la recherché sur l’human, CHUS Hospital Fleurimont, Fleurimont, QC
	University of Western Ontario, London, ON
	University Health Network Research Ethics Board Toronto General Hospital, Toronto, ON
	Health Research Ethics Board Panel, University of Alberta, Edmonton, Alberta
	Research Ethics Board Capital District Health Authority, Halifax, NS
	University of Saskatchewan Advisory Committee on Ethics in Human Experimentation, Saskatoon, SK
New Zealand	Canterbury Ethics Committee, Christchurch
	Auckland Ethics Committees, Auckland
Czech Republic	Charles University, Prague
	EC Mulac Hospital, Pilsen
	Ethics Committee at Bulovka University Hospital, Prague
	Faculty Hospital of Charles, University Pilsen, Pilsen
	EC of FN v Motole, Prague
	Eticka komise, Masarykova nemocnice, Ustf nad Labem
	Clinicum a.s., NsP Vysocany, Prosek, Prague
	Ethics Committee of the University Hospital in Plzen, Plzen
Australia	South Eastern Sydney Area Health Service Research Ethics Committee, Randwick, New South Wales
	Alfred Hospital Ethics Committee, Melbourne, Victoria
	Northern Hospital Human Research Ethics Committee, Epping, Victoria
	Royal Brisbane Hospital Research Ethics Committee, Herston, Queensland
	Royal Melbourne Hospital Research Ethics Committee, Parkville, Victoria
	Austin and Repatriation Medical Centre Human Research Ethics Committee, Heidelberg, Victoria
South Africa	Pharma Ethics, Centurion
Bulgaria	Ethical Review Board 2nd Specialized Hospital for Active Treatment for Gynecology and Obstetrics, Sophia
	Committee of Science Ethic Multifunctional Hospital for Active Treatment, Plodiv
	Local Ethics Committee MHAT Alexandrovska, Sophia
	Independent Ethics Committee at MHAT-Pleven, Pleven
	Local Ethics Committee MHAT and Emergency Medicine-N.I. Pirogov, Sophia
Finland	Satakunnan sairaanhoitopiiri Eettinen toimikunta/Esa Ahiqvist, Pori
Poland	Komisja Bioctyczna przy Akademii, Medyczncj w Poznaniu, Poznan
	Komisja Bioctyczna przy, Okregowej Izbie Iekarskiej w, Krakow
	Komisja Bioctytczna przy, Akademii Medycznej, Warszawa
Romania	National Drug Agency, Bucuresti
	National Ethics Committee, Bucuresti
Ukraine	Central Ethics Committee, Kiev