Synergistic Effect of Ibuprofen and Hydromorphone for Postoperative Pain

Breast Cancer Clinical Trial

Official title:

Synergistic Effect of Ibuprofen and Hydromorphone for Postoperative Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02461056
• Other study ID #: 2014-03-108
• Status: Completed
• Phase: N/A
• First received: May 28, 2015
• Last updated: June 2, 2015
• Start date: June 2014
• Est. completion date: July 2014

Study information

• Verified date: May 2015
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 80 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) physical status ? or ?? who were able to communicate and understand the pain scales

Exclusion Criteria:

• any contraindication to the use of ibuprofen or hydromorphone

• a history of allergy or hypersensitivity

• a calculated creatinine clearance of <75 mL/min

• the presence or history of asthma, bleeding tendency, coronary artery bypass graft (CABG) surgery, heart failure, peptic ulcer disease, inflammatory bowel disease or any other gastrointestinal disorder, and renal or hepatic disease

• pregnancy

• age younger than 18 yr

• intraoperative use of regional anesthesia

• intraoperative administration of analgesics other than remifentanil

• postoperative pain =3 on a NRS in the post-anesthesia care unit (PACU)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Pain, Postoperative

Intervention

Drug:
• Ibuprofen
Drug was administered by the Dixon and Mood up-and-down method. Starting doses was ibuprofen 50 mg. The maximum doses was ibuprofen 800 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.
• Hydromorphone
Drug was administered by the Dixon and Mood up-and-down method. Starting doses was hydromorphone 0.25 mg. The maximum doses was hydromorphone 2 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.

Locations

Country	Name	City	State
Korea, Republic of	Samsung medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain scores on the numeric rating scale (NRS)		postoperative 1 hour	No