A Multi-Center, Randomized, Double-Blind Placebo-Controlled Trial of Intravenous-Ibuprofen (IV-Ibuprofen) for Treatment of Pain in Post-Operative Orthopedic Adult Patients
Objective. To determine whether pre‐ and post‐operative administration of intravenous ibuprofen (IV‐ibuprofen) can significantly decrease pain and morphine use when compared with placebo in adult orthopedic surgical patients. Design. This was a multi‐center, randomized, double‐blind placebo‐contro...
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| Veröffentlicht in: | Pain medicine (Malden, Mass.) Mass.), 2010-08, Vol.11 (8), p.1284-1293 |
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| creator | Singla, Neil Rock, Amy Pavliv, Leo |
| description | Objective. To determine whether pre‐ and post‐operative administration of intravenous ibuprofen (IV‐ibuprofen) can significantly decrease pain and morphine use when compared with placebo in adult orthopedic surgical patients.
Design. This was a multi‐center, randomized, double‐blind placebo‐controlled trial.
Setting. This study was completed at eight hospitals; six in the United States and two in South Africa.
Patients. A total of 185 adult patients undergoing elective orthopedic surgery.
Interventions. Patients were randomized to receive either 800 mg IV‐ibuprofen or placebo every 6 hours, with the first dose administered pre‐operatively. Additionally, all patients had access to intravenous morphine for rescue.
Outcome Measures. Efficacy of IV‐ibuprofen was demonstrated by measuring the patient's self assessment of pain using a visual analog scale (VAS; assessed with movement and at rest) and a verbal response scale (VRS). Morphine consumption during the post‐operative period was also assessed.
Results. In the immediate post‐operative period, there was a 25.8% reduction in mean area under the curve‐VAS assessed with movement (AUC‐VASM) in patients receiving IV‐ibuprofen (P |
| doi_str_mv | 10.1111/j.1526-4637.2010.00896.x |
| format | Article |
| fullrecord | <record><control><sourceid>istex_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_2955972</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>ark_67375_WNG_GQ03J3QW_0</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4406-28b9ff07919540712b98f57c70928c84b33cee1f66f04fbb1c5bdcd27670427b3</originalsourceid><addsrcrecordid>eNqNkm1v0zAQxyMEYmPwFZBfgrQUPyRxIiGkUkYp2miHBntp2c6Zubhx5CSl4yvxJXHoKPAOy5LPd_e78-nvJEEET0hcL9YTktMizQrGJxRHL8ZlVUx295LjQ-D-nU0Zz4-SR123xpgUWckeJkcUF7gijBwnP6boYnC9TWfQ9BBO0UfZ1H5jv0N9it74QTlIXzvb1GjlpAbl05lv-uCdgxpdBSsd8gYtoktuofFDly7U0AZvoEHPFp__3J4j40MkQPab2GqkVtI2KO6V7_p02UKQvd0CWob-xrdQW42mdXxbzOttRLrHyQMjXQdP7s6T5NPbs6vZu_R8OV_MpuepzjIcBy5VZQzmFanyDHNCVVWanGuOK1rqMlOMaQBiisLgzChFdK5qXVNecJxRrthJ8mpftx3UBmoN43ROtMFuZLgVXlrxb6SxN-KL3wpa5XnFaSxQ7gvo4LsugDmwBItRQLEWozZi1EmMAopfAopdRJ_-3fsA_lYsJrzcJ3yzDm7_u7BYXZxFI-LpHrddD7sDLsNXUfD4U8T1h7mYX2L2nl1eC8x-AnK_u-k</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype></control><display><type>article</type><title>A Multi-Center, Randomized, Double-Blind Placebo-Controlled Trial of Intravenous-Ibuprofen (IV-Ibuprofen) for Treatment of Pain in Post-Operative Orthopedic Adult Patients</title><source>MEDLINE</source><source>Access via Wiley Online Library</source><source>Oxford University Press Journals All Titles (1996-Current)</source><creator>Singla, Neil ; Rock, Amy ; Pavliv, Leo</creator><creatorcontrib>Singla, Neil ; Rock, Amy ; Pavliv, Leo</creatorcontrib><description>Objective. To determine whether pre‐ and post‐operative administration of intravenous ibuprofen (IV‐ibuprofen) can significantly decrease pain and morphine use when compared with placebo in adult orthopedic surgical patients.
Design. This was a multi‐center, randomized, double‐blind placebo‐controlled trial.
Setting. This study was completed at eight hospitals; six in the United States and two in South Africa.
Patients. A total of 185 adult patients undergoing elective orthopedic surgery.
Interventions. Patients were randomized to receive either 800 mg IV‐ibuprofen or placebo every 6 hours, with the first dose administered pre‐operatively. Additionally, all patients had access to intravenous morphine for rescue.
Outcome Measures. Efficacy of IV‐ibuprofen was demonstrated by measuring the patient's self assessment of pain using a visual analog scale (VAS; assessed with movement and at rest) and a verbal response scale (VRS). Morphine consumption during the post‐operative period was also assessed.
Results. In the immediate post‐operative period, there was a 25.8% reduction in mean area under the curve‐VAS assessed with movement (AUC‐VASM) in patients receiving IV‐ibuprofen (P < 0.001); a 31.8% reduction in mean AUC‐VAS assessed at rest (AUC‐VASR; P < 0.001) and a 20.2% reduction in mean VRS (P < 0.001) compared to those receiving placebo. Patients receiving IV‐ibuprofen used 30.9% less morphine (P < 0.001) compared to those receiving placebo. Similar treatment emergent adverse events occurred in both study groups and there were no significant differences in the incidence of serious adverse events.
Conclusion. Pre‐ and post‐operative administration of IV‐ibuprofen significantly reduced both pain and morphine use in orthopedic surgery patients in this prospective randomized placebo‐controlled trial.</description><identifier>ISSN: 1526-2375</identifier><identifier>EISSN: 1526-4637</identifier><identifier>DOI: 10.1111/j.1526-4637.2010.00896.x</identifier><identifier>PMID: 20609131</identifier><language>eng</language><publisher>Malden, USA: Blackwell Publishing Inc</publisher><subject>Acute Pain Section ; Adult ; Aged ; Aged, 80 and over ; Analgesic ; Analgesics, Non-Narcotic - therapeutic use ; Analgesics, Opioid - therapeutic use ; Area Under Curve ; Double-Blind Method ; Female ; Humans ; Ibuprofen ; Ibuprofen - administration & dosage ; Ibuprofen - therapeutic use ; Injections, Intravenous ; Male ; Middle Aged ; Morphine - therapeutic use ; NSAID ; Opioid ; Orthopedic Procedures ; Pain ; Pain, Postoperative - drug therapy ; Placebos - therapeutic use ; Post-Operative ; Treatment Outcome</subject><ispartof>Pain medicine (Malden, Mass.), 2010-08, Vol.11 (8), p.1284-1293</ispartof><rights>Wiley Periodicals, Inc.</rights><rights>2010 American Academy of Pain Medicine</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4406-28b9ff07919540712b98f57c70928c84b33cee1f66f04fbb1c5bdcd27670427b3</citedby><cites>FETCH-LOGICAL-c4406-28b9ff07919540712b98f57c70928c84b33cee1f66f04fbb1c5bdcd27670427b3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fj.1526-4637.2010.00896.x$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fj.1526-4637.2010.00896.x$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>230,314,780,784,885,1417,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20609131$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Singla, Neil</creatorcontrib><creatorcontrib>Rock, Amy</creatorcontrib><creatorcontrib>Pavliv, Leo</creatorcontrib><title>A Multi-Center, Randomized, Double-Blind Placebo-Controlled Trial of Intravenous-Ibuprofen (IV-Ibuprofen) for Treatment of Pain in Post-Operative Orthopedic Adult Patients</title><title>Pain medicine (Malden, Mass.)</title><addtitle>Pain Med</addtitle><description>Objective. To determine whether pre‐ and post‐operative administration of intravenous ibuprofen (IV‐ibuprofen) can significantly decrease pain and morphine use when compared with placebo in adult orthopedic surgical patients.
Design. This was a multi‐center, randomized, double‐blind placebo‐controlled trial.
Setting. This study was completed at eight hospitals; six in the United States and two in South Africa.
Patients. A total of 185 adult patients undergoing elective orthopedic surgery.
Interventions. Patients were randomized to receive either 800 mg IV‐ibuprofen or placebo every 6 hours, with the first dose administered pre‐operatively. Additionally, all patients had access to intravenous morphine for rescue.
Outcome Measures. Efficacy of IV‐ibuprofen was demonstrated by measuring the patient's self assessment of pain using a visual analog scale (VAS; assessed with movement and at rest) and a verbal response scale (VRS). Morphine consumption during the post‐operative period was also assessed.
Results. In the immediate post‐operative period, there was a 25.8% reduction in mean area under the curve‐VAS assessed with movement (AUC‐VASM) in patients receiving IV‐ibuprofen (P < 0.001); a 31.8% reduction in mean AUC‐VAS assessed at rest (AUC‐VASR; P < 0.001) and a 20.2% reduction in mean VRS (P < 0.001) compared to those receiving placebo. Patients receiving IV‐ibuprofen used 30.9% less morphine (P < 0.001) compared to those receiving placebo. Similar treatment emergent adverse events occurred in both study groups and there were no significant differences in the incidence of serious adverse events.
Conclusion. Pre‐ and post‐operative administration of IV‐ibuprofen significantly reduced both pain and morphine use in orthopedic surgery patients in this prospective randomized placebo‐controlled trial.</description><subject>Acute Pain Section</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Analgesic</subject><subject>Analgesics, Non-Narcotic - therapeutic use</subject><subject>Analgesics, Opioid - therapeutic use</subject><subject>Area Under Curve</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Humans</subject><subject>Ibuprofen</subject><subject>Ibuprofen - administration & dosage</subject><subject>Ibuprofen - therapeutic use</subject><subject>Injections, Intravenous</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Morphine - therapeutic use</subject><subject>NSAID</subject><subject>Opioid</subject><subject>Orthopedic Procedures</subject><subject>Pain</subject><subject>Pain, Postoperative - drug therapy</subject><subject>Placebos - therapeutic use</subject><subject>Post-Operative</subject><subject>Treatment Outcome</subject><issn>1526-2375</issn><issn>1526-4637</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>WIN</sourceid><sourceid>EIF</sourceid><recordid>eNqNkm1v0zAQxyMEYmPwFZBfgrQUPyRxIiGkUkYp2miHBntp2c6Zubhx5CSl4yvxJXHoKPAOy5LPd_e78-nvJEEET0hcL9YTktMizQrGJxRHL8ZlVUx295LjQ-D-nU0Zz4-SR123xpgUWckeJkcUF7gijBwnP6boYnC9TWfQ9BBO0UfZ1H5jv0N9it74QTlIXzvb1GjlpAbl05lv-uCdgxpdBSsd8gYtoktuofFDly7U0AZvoEHPFp__3J4j40MkQPab2GqkVtI2KO6V7_p02UKQvd0CWob-xrdQW42mdXxbzOttRLrHyQMjXQdP7s6T5NPbs6vZu_R8OV_MpuepzjIcBy5VZQzmFanyDHNCVVWanGuOK1rqMlOMaQBiisLgzChFdK5qXVNecJxRrthJ8mpftx3UBmoN43ROtMFuZLgVXlrxb6SxN-KL3wpa5XnFaSxQ7gvo4LsugDmwBItRQLEWozZi1EmMAopfAopdRJ_-3fsA_lYsJrzcJ3yzDm7_u7BYXZxFI-LpHrddD7sDLsNXUfD4U8T1h7mYX2L2nl1eC8x-AnK_u-k</recordid><startdate>201008</startdate><enddate>201008</enddate><creator>Singla, Neil</creator><creator>Rock, Amy</creator><creator>Pavliv, Leo</creator><general>Blackwell Publishing Inc</general><scope>BSCLL</scope><scope>24P</scope><scope>WIN</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>5PM</scope></search><sort><creationdate>201008</creationdate><title>A Multi-Center, Randomized, Double-Blind Placebo-Controlled Trial of Intravenous-Ibuprofen (IV-Ibuprofen) for Treatment of Pain in Post-Operative Orthopedic Adult Patients</title><author>Singla, Neil ; Rock, Amy ; Pavliv, Leo</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4406-28b9ff07919540712b98f57c70928c84b33cee1f66f04fbb1c5bdcd27670427b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Acute Pain Section</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Analgesic</topic><topic>Analgesics, Non-Narcotic - therapeutic use</topic><topic>Analgesics, Opioid - therapeutic use</topic><topic>Area Under Curve</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Humans</topic><topic>Ibuprofen</topic><topic>Ibuprofen - administration & dosage</topic><topic>Ibuprofen - therapeutic use</topic><topic>Injections, Intravenous</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Morphine - therapeutic use</topic><topic>NSAID</topic><topic>Opioid</topic><topic>Orthopedic Procedures</topic><topic>Pain</topic><topic>Pain, Postoperative - drug therapy</topic><topic>Placebos - therapeutic use</topic><topic>Post-Operative</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Singla, Neil</creatorcontrib><creatorcontrib>Rock, Amy</creatorcontrib><creatorcontrib>Pavliv, Leo</creatorcontrib><collection>Istex</collection><collection>Wiley Online Library Open Access</collection><collection>Wiley Online Library (Open Access Collection)</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Pain medicine (Malden, Mass.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Singla, Neil</au><au>Rock, Amy</au><au>Pavliv, Leo</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A Multi-Center, Randomized, Double-Blind Placebo-Controlled Trial of Intravenous-Ibuprofen (IV-Ibuprofen) for Treatment of Pain in Post-Operative Orthopedic Adult Patients</atitle><jtitle>Pain medicine (Malden, Mass.)</jtitle><addtitle>Pain Med</addtitle><date>2010-08</date><risdate>2010</risdate><volume>11</volume><issue>8</issue><spage>1284</spage><epage>1293</epage><pages>1284-1293</pages><issn>1526-2375</issn><eissn>1526-4637</eissn><abstract>Objective. To determine whether pre‐ and post‐operative administration of intravenous ibuprofen (IV‐ibuprofen) can significantly decrease pain and morphine use when compared with placebo in adult orthopedic surgical patients.
Design. This was a multi‐center, randomized, double‐blind placebo‐controlled trial.
Setting. This study was completed at eight hospitals; six in the United States and two in South Africa.
Patients. A total of 185 adult patients undergoing elective orthopedic surgery.
Interventions. Patients were randomized to receive either 800 mg IV‐ibuprofen or placebo every 6 hours, with the first dose administered pre‐operatively. Additionally, all patients had access to intravenous morphine for rescue.
Outcome Measures. Efficacy of IV‐ibuprofen was demonstrated by measuring the patient's self assessment of pain using a visual analog scale (VAS; assessed with movement and at rest) and a verbal response scale (VRS). Morphine consumption during the post‐operative period was also assessed.
Results. In the immediate post‐operative period, there was a 25.8% reduction in mean area under the curve‐VAS assessed with movement (AUC‐VASM) in patients receiving IV‐ibuprofen (P < 0.001); a 31.8% reduction in mean AUC‐VAS assessed at rest (AUC‐VASR; P < 0.001) and a 20.2% reduction in mean VRS (P < 0.001) compared to those receiving placebo. Patients receiving IV‐ibuprofen used 30.9% less morphine (P < 0.001) compared to those receiving placebo. Similar treatment emergent adverse events occurred in both study groups and there were no significant differences in the incidence of serious adverse events.
Conclusion. Pre‐ and post‐operative administration of IV‐ibuprofen significantly reduced both pain and morphine use in orthopedic surgery patients in this prospective randomized placebo‐controlled trial.</abstract><cop>Malden, USA</cop><pub>Blackwell Publishing Inc</pub><pmid>20609131</pmid><doi>10.1111/j.1526-4637.2010.00896.x</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 1526-2375 |
| ispartof | Pain medicine (Malden, Mass.), 2010-08, Vol.11 (8), p.1284-1293 |
| issn | 1526-2375 1526-4637 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_2955972 |
| source | MEDLINE; Access via Wiley Online Library; Oxford University Press Journals All Titles (1996-Current) |
| subjects | Acute Pain Section Adult Aged Aged, 80 and over Analgesic Analgesics, Non-Narcotic - therapeutic use Analgesics, Opioid - therapeutic use Area Under Curve Double-Blind Method Female Humans Ibuprofen Ibuprofen - administration & dosage Ibuprofen - therapeutic use Injections, Intravenous Male Middle Aged Morphine - therapeutic use NSAID Opioid Orthopedic Procedures Pain Pain, Postoperative - drug therapy Placebos - therapeutic use Post-Operative Treatment Outcome |
| title | A Multi-Center, Randomized, Double-Blind Placebo-Controlled Trial of Intravenous-Ibuprofen (IV-Ibuprofen) for Treatment of Pain in Post-Operative Orthopedic Adult Patients |
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