Prophylactic Compared With Therapeutic Ibuprofen Analgesia in First-Trimester Medical Abortion: A Randomized Controlled Trial
OBJECTIVE:To compare the effectiveness of two oral analgesic regimens in first-trimester medical abortion. METHODS:We randomly assigned 250 participants undergoing first-trimester abortion with mifepristone and misoprostol at three clinics to two ibuprofen regimenstherapeutic (800 mg every 4–6 hours...
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Veröffentlicht in: | Obstetrics and gynecology (New York. 1953) 2013-09, Vol.122 (3), p.558-564 |
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container_title | Obstetrics and gynecology (New York. 1953) |
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creator | Raymond, Elizabeth G. Weaver, Mark A. Louie, Karmen S. Dean, Gillian Porsch, Lauren Lichtenberg, E. Steve Ali, Rose Arnesen, Michelle |
description | OBJECTIVE:To compare the effectiveness of two oral analgesic regimens in first-trimester medical abortion.
METHODS:We randomly assigned 250 participants undergoing first-trimester abortion with mifepristone and misoprostol at three clinics to two ibuprofen regimenstherapeutic (800 mg every 4–6 hours as needed for pain) or prophylactic (800 mg starting 1 hour before the misoprostol dose, then every 4–6 hours for 48 hours regardless of pain, then as needed). We asked each participant to record her maximum pain on a scale of 0–10 daily thereafter.
RESULTS:Of participants assigned to the prophylactic and therapeutic regimens, 111 of 123 (90%) and 117 of 127 (92%), respectively, provided follow-up data. More than 80% of the participants in each group complied with their assigned treatment. Participants in the prophylactic group used substantially more ibuprofen than those in the therapeutic group (median of nine and four tablets, respectively). The mean maximum pain score was 7.1 in the prophylactic group and 7.3 in the therapeutic group (standard deviations 2.5 and 2.2, respectively); the difference was not statistically significant (P=.87, adjusted for site). Duration of pain, verbal pain ratings reported at follow-up, and use of other analgesics did not differ significantly by group (all P>.05). No significant benefit of the prophylactic regimen was apparent in any population subgroup. Abortion failure and ibuprofen side effects in the two groups were similar.
CONCLUSION:We found no evidence that prophylactic administration of ibuprofen reduces pain severity or duration in first-trimester medical abortion. The average pain severity experienced by participants using both regimens was high.
CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov, www.clinicaltrials.gov, NCT01457521.
LEVEL OF EVIDENCE:I |
doi_str_mv | 10.1097/AOG.0b013e31829d5a33 |
format | Article |
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METHODS:We randomly assigned 250 participants undergoing first-trimester abortion with mifepristone and misoprostol at three clinics to two ibuprofen regimenstherapeutic (800 mg every 4–6 hours as needed for pain) or prophylactic (800 mg starting 1 hour before the misoprostol dose, then every 4–6 hours for 48 hours regardless of pain, then as needed). We asked each participant to record her maximum pain on a scale of 0–10 daily thereafter.
RESULTS:Of participants assigned to the prophylactic and therapeutic regimens, 111 of 123 (90%) and 117 of 127 (92%), respectively, provided follow-up data. More than 80% of the participants in each group complied with their assigned treatment. Participants in the prophylactic group used substantially more ibuprofen than those in the therapeutic group (median of nine and four tablets, respectively). The mean maximum pain score was 7.1 in the prophylactic group and 7.3 in the therapeutic group (standard deviations 2.5 and 2.2, respectively); the difference was not statistically significant (P=.87, adjusted for site). Duration of pain, verbal pain ratings reported at follow-up, and use of other analgesics did not differ significantly by group (all P>.05). No significant benefit of the prophylactic regimen was apparent in any population subgroup. Abortion failure and ibuprofen side effects in the two groups were similar.
CONCLUSION:We found no evidence that prophylactic administration of ibuprofen reduces pain severity or duration in first-trimester medical abortion. The average pain severity experienced by participants using both regimens was high.
CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov, www.clinicaltrials.gov, NCT01457521.
LEVEL OF EVIDENCE:I</description><identifier>ISSN: 0029-7844</identifier><identifier>EISSN: 1873-233X</identifier><identifier>DOI: 10.1097/AOG.0b013e31829d5a33</identifier><identifier>PMID: 23921857</identifier><language>eng</language><publisher>United States: by The American College of Obstetricians and Gynecologists</publisher><subject>Abortifacient Agents, Steroidal ; Abortion, Induced ; Adolescent ; Adult ; Analgesia - methods ; Analgesics, Non-Narcotic - administration & dosage ; Female ; Humans ; Ibuprofen - administration & dosage ; Mifepristone ; Misoprostol ; Pregnancy ; Pregnancy Trimester, First ; Young Adult</subject><ispartof>Obstetrics and gynecology (New York. 1953), 2013-09, Vol.122 (3), p.558-564</ispartof><rights>2013 by The American College of Obstetricians and Gynecologists.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c3053-cd7af5e3c5c89c100acd5fae71737796548fd4ec0c0edce028c5455080e726f33</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23921857$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Raymond, Elizabeth G.</creatorcontrib><creatorcontrib>Weaver, Mark A.</creatorcontrib><creatorcontrib>Louie, Karmen S.</creatorcontrib><creatorcontrib>Dean, Gillian</creatorcontrib><creatorcontrib>Porsch, Lauren</creatorcontrib><creatorcontrib>Lichtenberg, E. Steve</creatorcontrib><creatorcontrib>Ali, Rose</creatorcontrib><creatorcontrib>Arnesen, Michelle</creatorcontrib><title>Prophylactic Compared With Therapeutic Ibuprofen Analgesia in First-Trimester Medical Abortion: A Randomized Controlled Trial</title><title>Obstetrics and gynecology (New York. 1953)</title><addtitle>Obstet Gynecol</addtitle><description>OBJECTIVE:To compare the effectiveness of two oral analgesic regimens in first-trimester medical abortion.
METHODS:We randomly assigned 250 participants undergoing first-trimester abortion with mifepristone and misoprostol at three clinics to two ibuprofen regimenstherapeutic (800 mg every 4–6 hours as needed for pain) or prophylactic (800 mg starting 1 hour before the misoprostol dose, then every 4–6 hours for 48 hours regardless of pain, then as needed). We asked each participant to record her maximum pain on a scale of 0–10 daily thereafter.
RESULTS:Of participants assigned to the prophylactic and therapeutic regimens, 111 of 123 (90%) and 117 of 127 (92%), respectively, provided follow-up data. More than 80% of the participants in each group complied with their assigned treatment. Participants in the prophylactic group used substantially more ibuprofen than those in the therapeutic group (median of nine and four tablets, respectively). The mean maximum pain score was 7.1 in the prophylactic group and 7.3 in the therapeutic group (standard deviations 2.5 and 2.2, respectively); the difference was not statistically significant (P=.87, adjusted for site). Duration of pain, verbal pain ratings reported at follow-up, and use of other analgesics did not differ significantly by group (all P>.05). No significant benefit of the prophylactic regimen was apparent in any population subgroup. Abortion failure and ibuprofen side effects in the two groups were similar.
CONCLUSION:We found no evidence that prophylactic administration of ibuprofen reduces pain severity or duration in first-trimester medical abortion. The average pain severity experienced by participants using both regimens was high.
CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov, www.clinicaltrials.gov, NCT01457521.
LEVEL OF EVIDENCE:I</description><subject>Abortifacient Agents, Steroidal</subject><subject>Abortion, Induced</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Analgesia - methods</subject><subject>Analgesics, Non-Narcotic - administration & dosage</subject><subject>Female</subject><subject>Humans</subject><subject>Ibuprofen - administration & dosage</subject><subject>Mifepristone</subject><subject>Misoprostol</subject><subject>Pregnancy</subject><subject>Pregnancy Trimester, First</subject><subject>Young Adult</subject><issn>0029-7844</issn><issn>1873-233X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kEFv1DAQhS1ERZfCP0DIRy4p4zheO71Fq7ZUKipCi-AWee0JcevEwU5UtRL_HVfb9tADpxlp3nsz8xHygcExg1p-bq7Oj2EHjCNnqqyt0Jy_IiumJC9Kzn-9JiuAsi6kqqpD8jalawBg65q_IYclr0umhFyRv99imPo7r83sDN2EYdIRLf3p5p5ue4x6wuVhcrFbphg6HGkzav8bk9PUjfTMxTQX2-gGTDNG-hWtM9rTZhfi7MJ4Qhv6XY82DO4-x27COMfgfW6zR_t35KDTPuH7x3pEfpydbjdfisur84tNc1kYDoIXxkrdCeRGGFUbBqCNFZ1GySSXsl6LSnW2QgMG0BqEUhlRCQEKUJbrjvMj8mmfm3_4s-RT28Elg97rEcOSWlaVMtORrMrSai81MaQUsWun_J2Ody2D9gF8m8G3L8Fn28fHDctuQPtseiKdBWovuA0-k0o3frnF2Pao_dz_P_sfw0-TcQ</recordid><startdate>201309</startdate><enddate>201309</enddate><creator>Raymond, Elizabeth G.</creator><creator>Weaver, Mark A.</creator><creator>Louie, Karmen S.</creator><creator>Dean, Gillian</creator><creator>Porsch, Lauren</creator><creator>Lichtenberg, E. Steve</creator><creator>Ali, Rose</creator><creator>Arnesen, Michelle</creator><general>by The American College of Obstetricians and Gynecologists</general><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>7X8</scope></search><sort><creationdate>201309</creationdate><title>Prophylactic Compared With Therapeutic Ibuprofen Analgesia in First-Trimester Medical Abortion: A Randomized Controlled Trial</title><author>Raymond, Elizabeth G. ; Weaver, Mark A. ; Louie, Karmen S. ; Dean, Gillian ; Porsch, Lauren ; Lichtenberg, E. Steve ; Ali, Rose ; Arnesen, Michelle</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3053-cd7af5e3c5c89c100acd5fae71737796548fd4ec0c0edce028c5455080e726f33</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Abortifacient Agents, Steroidal</topic><topic>Abortion, Induced</topic><topic>Adolescent</topic><topic>Adult</topic><topic>Analgesia - methods</topic><topic>Analgesics, Non-Narcotic - administration & dosage</topic><topic>Female</topic><topic>Humans</topic><topic>Ibuprofen - administration & dosage</topic><topic>Mifepristone</topic><topic>Misoprostol</topic><topic>Pregnancy</topic><topic>Pregnancy Trimester, First</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Raymond, Elizabeth G.</creatorcontrib><creatorcontrib>Weaver, Mark A.</creatorcontrib><creatorcontrib>Louie, Karmen S.</creatorcontrib><creatorcontrib>Dean, Gillian</creatorcontrib><creatorcontrib>Porsch, Lauren</creatorcontrib><creatorcontrib>Lichtenberg, E. Steve</creatorcontrib><creatorcontrib>Ali, Rose</creatorcontrib><creatorcontrib>Arnesen, Michelle</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Obstetrics and gynecology (New York. 1953)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Raymond, Elizabeth G.</au><au>Weaver, Mark A.</au><au>Louie, Karmen S.</au><au>Dean, Gillian</au><au>Porsch, Lauren</au><au>Lichtenberg, E. Steve</au><au>Ali, Rose</au><au>Arnesen, Michelle</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Prophylactic Compared With Therapeutic Ibuprofen Analgesia in First-Trimester Medical Abortion: A Randomized Controlled Trial</atitle><jtitle>Obstetrics and gynecology (New York. 1953)</jtitle><addtitle>Obstet Gynecol</addtitle><date>2013-09</date><risdate>2013</risdate><volume>122</volume><issue>3</issue><spage>558</spage><epage>564</epage><pages>558-564</pages><issn>0029-7844</issn><eissn>1873-233X</eissn><abstract>OBJECTIVE:To compare the effectiveness of two oral analgesic regimens in first-trimester medical abortion.
METHODS:We randomly assigned 250 participants undergoing first-trimester abortion with mifepristone and misoprostol at three clinics to two ibuprofen regimenstherapeutic (800 mg every 4–6 hours as needed for pain) or prophylactic (800 mg starting 1 hour before the misoprostol dose, then every 4–6 hours for 48 hours regardless of pain, then as needed). We asked each participant to record her maximum pain on a scale of 0–10 daily thereafter.
RESULTS:Of participants assigned to the prophylactic and therapeutic regimens, 111 of 123 (90%) and 117 of 127 (92%), respectively, provided follow-up data. More than 80% of the participants in each group complied with their assigned treatment. Participants in the prophylactic group used substantially more ibuprofen than those in the therapeutic group (median of nine and four tablets, respectively). The mean maximum pain score was 7.1 in the prophylactic group and 7.3 in the therapeutic group (standard deviations 2.5 and 2.2, respectively); the difference was not statistically significant (P=.87, adjusted for site). Duration of pain, verbal pain ratings reported at follow-up, and use of other analgesics did not differ significantly by group (all P>.05). No significant benefit of the prophylactic regimen was apparent in any population subgroup. Abortion failure and ibuprofen side effects in the two groups were similar.
CONCLUSION:We found no evidence that prophylactic administration of ibuprofen reduces pain severity or duration in first-trimester medical abortion. The average pain severity experienced by participants using both regimens was high.
CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov, www.clinicaltrials.gov, NCT01457521.
LEVEL OF EVIDENCE:I</abstract><cop>United States</cop><pub>by The American College of Obstetricians and Gynecologists</pub><pmid>23921857</pmid><doi>10.1097/AOG.0b013e31829d5a33</doi><tpages>7</tpages></addata></record> |
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subjects | Abortifacient Agents, Steroidal Abortion, Induced Adolescent Adult Analgesia - methods Analgesics, Non-Narcotic - administration & dosage Female Humans Ibuprofen - administration & dosage Mifepristone Misoprostol Pregnancy Pregnancy Trimester, First Young Adult |
title | Prophylactic Compared With Therapeutic Ibuprofen Analgesia in First-Trimester Medical Abortion: A Randomized Controlled Trial |
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