TY - JOUR
T1 - Hydrocodone-acetaminophen for pain control in first-trimester surgical abortion
T2 - A randomized controlled trial
AU - Micks, Elizabeth A.
AU - Edelman, Alison B.
AU - Renner, Regina Maria
AU - Fu, Rongwei
AU - Lambert, William
AU - Bednarek, Paula H.
AU - Nichols, Mark D.
AU - Beckley, Ethan H.
AU - Jensen, Jeffrey T.
PY - 2012/11
Y1 - 2012/11
N2 - Objective: Although hydrocodone-acetaminophen is commonly used for pain control in first-trimester abortion, the efficacy of oral opioids for decreasing pain has not been established. Our objective was to estimate the effect of hydrocodone-acetaminophen on patient pain perception during first-trimester surgical abortion. Methods: We conducted a randomized, double-blinded, placebo-controlled trial. Patients (before 11 weeks of gestation) received standard premedication (ibuprofen and lorazepam) and a paracervical block with the addition of 10 mg hydrocodone and 650 mg acetaminophen or placebo 45-90 minutes before surgical abortion. A sample size of 120 was calculated to provide 80% power to show a 15-mm difference (α=0.05) in the primary outcome of pain with uterine aspiration (100-mm visual analog scale). Secondary outcomes were pain at additional time points, satisfaction, side effects, adverse events, and need for additional pain medications. Results: There were no significant differences in demographics or baseline pain between groups. There were no differences in pain scores between patients receiving hydrocodone-acetaminophen compared with placebo during uterine aspiration (65.7 mm compared with 63.2 mm, P=.59) or other procedural time points. There were no differences in satisfaction or need for additional pain medications. Patients who received hydrocodone-acetaminophen had more postoperative nausea than those receiving placebo (P=.03) when controlling for baseline nausea. No medication-related adverse events were noted. Conclusion: Hydrocodone-acetaminophen does not decrease pain during first-trimester abortion and may increase postoperative nausea. Clinical Trial Registration: Clinicaltrials.gov, www.clinicaltrials.gov, NCT01330459.
AB - Objective: Although hydrocodone-acetaminophen is commonly used for pain control in first-trimester abortion, the efficacy of oral opioids for decreasing pain has not been established. Our objective was to estimate the effect of hydrocodone-acetaminophen on patient pain perception during first-trimester surgical abortion. Methods: We conducted a randomized, double-blinded, placebo-controlled trial. Patients (before 11 weeks of gestation) received standard premedication (ibuprofen and lorazepam) and a paracervical block with the addition of 10 mg hydrocodone and 650 mg acetaminophen or placebo 45-90 minutes before surgical abortion. A sample size of 120 was calculated to provide 80% power to show a 15-mm difference (α=0.05) in the primary outcome of pain with uterine aspiration (100-mm visual analog scale). Secondary outcomes were pain at additional time points, satisfaction, side effects, adverse events, and need for additional pain medications. Results: There were no significant differences in demographics or baseline pain between groups. There were no differences in pain scores between patients receiving hydrocodone-acetaminophen compared with placebo during uterine aspiration (65.7 mm compared with 63.2 mm, P=.59) or other procedural time points. There were no differences in satisfaction or need for additional pain medications. Patients who received hydrocodone-acetaminophen had more postoperative nausea than those receiving placebo (P=.03) when controlling for baseline nausea. No medication-related adverse events were noted. Conclusion: Hydrocodone-acetaminophen does not decrease pain during first-trimester abortion and may increase postoperative nausea. Clinical Trial Registration: Clinicaltrials.gov, www.clinicaltrials.gov, NCT01330459.
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U2 - 10.1097/AOG.0b013e31826c32f0
DO - 10.1097/AOG.0b013e31826c32f0
M3 - Article
C2 - 23090523
AN - SCOPUS:84868156772
SN - 0029-7844
VL - 120
SP - 1060
EP - 1069
JO - Obstetrics and gynecology
JF - Obstetrics and gynecology
IS - 5
ER -