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Spots Global Cancer Trial Database for Synergistic Effect of Ibuprofen and Hydromorphone for Postoperative Pain

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Trial Identification

Brief Title: Synergistic Effect of Ibuprofen and Hydromorphone for Postoperative Pain

Official Title: Synergistic Effect of Ibuprofen and Hydromorphone for Postoperative Pain

Study ID: NCT02461056

Conditions

Breast Cancer

Study Description

Brief Summary: Intravenous form of ibuprofen is recently approved by FDA and reports are rare on the co-administration with opioids. The investigators searched whether intravenous ibuprofen-hydromorphone combination is synergistic, additive, or infra-additive on postoperative pain using combination index (CI), dose reduction index (DRI) and isobologram.

Detailed Description: Ninety patients, undergoing breast surgery, were included in one of the three groups (Ibuprofen, Hydromorphone, Ibuprofen+Hydromorphone groups). Positive analgesic efficacy was defined as a numeric rating scale (NRS) ≤3 on a 0-10 NRS, 30 min after the drug administration. Drug was administered by the Dixon and Mood up-and-down method. Starting doses were ibuprofen 50 mg, hydromorphone 0.25 mg, or ibuprofen 25 mg + hydromorphone 0.125 mg. 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.

Eligibility

Minimum Age: 19 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Samsung medical center, Seoul, , Korea, Republic of

Contact Details

Name: Hyun Joo Ahn, Ph.D.

Affiliation: Samsung Medical Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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