- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02461056
Synergistic Effect of Ibuprofen and Hydromorphone for Postoperative Pain
June 2, 2015 updated by: Hyun Joo Ahn, Samsung Medical Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Seoul, Korea, Republic of, 135-710
- Samsung Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) physical status І or ІІ 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Ibuprofen
Ibuprofen: Patients receive ibuprofen 50 mg, 100 mg, 200 mg, 400mg or 800 mg intravenously once at post-anesthesia care unit.
|
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.
Other Names:
|
Active Comparator: hydromorphone
Hydromorphone: Patients receive hydromorphone 0.25 mg, 0.5 mg, 1 mg, 1.5 mg, or 2 mg intravenously once at post-anesthesia care unit.
|
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.
Other Names:
|
Active Comparator: ibuprofen+hydromorphone
Ibuprofen+Hydromorphone: Patients receive ibuprofen 25 mg + hydromorphone 0.125 mg, ibuprofen 50 mg + hydromorphone 0.25 mg, ibuprofen 100 mg + hydromorphone 0.5 mg, ibuprofen 200 mg + hydromorphone 0.75 mg, or ibuprofen 400 mg + hydromorphone 1 mg intravenously once at post-anesthesia care unit.
|
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.
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain scores on the numeric rating scale (NRS)
Time Frame: postoperative 1 hour
|
postoperative 1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hyun Joo Ahn, Ph.D., Samsung Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2014
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
July 1, 2014
Study Registration Dates
First Submitted
May 28, 2015
First Submitted That Met QC Criteria
June 2, 2015
First Posted (Estimate)
June 3, 2015
Study Record Updates
Last Update Posted (Estimate)
June 3, 2015
Last Update Submitted That Met QC Criteria
June 2, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Analgesics, Opioid
- Narcotics
- Ibuprofen
- Hydromorphone
Other Study ID Numbers
- 2014-03-108
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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