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Synergistic Effect of Ibuprofen and Hydromorphone for Postoperative Pain

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ClinicalTrials.gov Identifier: NCT02461056
Recruitment Status : Completed
First Posted : June 3, 2015
Last Update Posted : June 3, 2015
Sponsor:
Information provided by (Responsible Party):
Hyun Joo Ahn, Samsung Medical Center

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Ibuprofen Drug: Hydromorphone Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Synergistic Effect of Ibuprofen and Hydromorphone for Postoperative Pain
Study Start Date : June 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014


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: 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.
Other Name: Caldolor

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: 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.
Other Name: Dilid

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: 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.
Other Name: Caldolor

Drug: 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.
Other Name: Dilid




Primary Outcome Measures :
  1. Pain scores on the numeric rating scale (NRS) [ Time Frame: postoperative 1 hour ]


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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02461056


Locations
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Korea, Republic of
Samsung medical center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Hyun Joo Ahn, Ph.D. Samsung Medical Center

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Responsible Party: Hyun Joo Ahn, Assoicate professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02461056     History of Changes
Other Study ID Numbers: 2014-03-108
First Posted: June 3, 2015    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: May 2015
Keywords provided by Hyun Joo Ahn, Samsung Medical Center:
ibuprofen
hydromorphone
drug interactions
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Ibuprofen
Hydromorphone
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Central Nervous System Depressants