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Randomized Controlled Trial
Synergistic Effect of Intravenous Ibuprofen and Hydromorphone for Postoperative Pain: Prospective Randomized Controlled Trial.
- Eunjung Oh, Hyun Joo Ahn, Woo Seog Sim, and Jin Young Lee.
- Samsung Medical Centre, Sungkyunkwan University School of Medicine Seoul, Republic of Korea.
- Pain Physician. 2016 Jul 1; 19 (6): 341-8.
BackgroundAn intravenous form of ibuprofen has recently been approved by the Food and Drug Administration (FDA) and reports are rare on its co-administration with opioids.ObjectivesWe researched whether an intravenous ibuprofen-hydromorphone combination is synergistic, additive, or infra-additive on postoperative pain.Study DesignA parallel-group, 1:1:1 allocation, randomized, double-blind controlled trial.SettingUniversity teaching hospital in Korea.MethodsNinety patients, undergoing breast surgery, were divided into one of the 3 groups (I, H, IH groups). Positive analgesic efficacy was defined as a numeric rating scale (NRS)= 3 on a 0 - 10 NRS, 30 minutes after the drug administration. Drugs were administered by the Dixon's up-and-down method. Starting doses were ibuprofen (I) 50 mg, hydromorphone (H) 0.25 mg, or ibuprofen 25 mg + hydromorphone 0.125 mg (IH). The maximum doses were ibuprofen 800 mg, hydromorphone 2 mg, or ibuprofen 400 mg + hydromorphone 1 mg. Combination index (CI) (additive: 0.9 - 1.1, synergism: < 0.9, antagonism: > 1.1), dose reduction index (DRI, a measure of how much the dose of each drug in a combination can be reduced), and isobologram were used to define the nature of their interaction.StatisticsOne way ANOVA, Kruskal Wallis test, and Chi square test, significance level P < 0.05.ResultsThe median effective doses (ED50) of ibuprofen and hydromorphone were 1,447 mg and 1.5 mg, respectively. The median ED50 of the combination was ibuprofen 71 mg and hydromorphone 0.3 mg. Ibuprofen and hydromorphone showed a strong synergy (CI 0.2, DRI 20 and 5 for ibuprofen and hydromorphone at ED50).LimitationAnalgesic efficacy was observed during post-anesthesia care unit (PACU) period only.ConclusionsThe combination of intravenous ibuprofen and hydromorphone produces a strong synergistic analgesia on postoperative pain.
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