Synergistic Effect of Ibuprofen and Hydromorphone for Postoperative Pain

NCT02461056 | Completed DMC

• 1 other identifier: 2014-03-108
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

ibuprofen; hydromorphone; drug interactions

Outcome Measures

Primary Outcomes (1)

• Pain scores on the numeric rating scale (NRS)

  postoperative 1 hour

Study Arms (3)

Ibuprofen

ACTIVE COMPARATOR

Ibuprofen: Patients receive ibuprofen 50 mg, 100 mg, 200 mg, 400mg or 800 mg intravenously once at post-anesthesia care unit.

Drug: Ibuprofen

hydromorphone

ACTIVE COMPARATOR

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

ibuprofen+hydromorphone

ACTIVE COMPARATOR

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: Hydromorphone

Interventions

Ibuprofen DRUG

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.

Also known as: Caldolor

Ibuprofen; ibuprofen+hydromorphone

Hydromorphone DRUG

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.

Also known as: Dilid

hydromorphone; ibuprofen+hydromorphone

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung medical center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Ibuprofen; Hydromorphone

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Hyun Joo Ahn, Ph.D.

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoicate professor

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: June 3, 2015
• Study Start: June 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: June 3, 2015

Record last verified: 2015-05

Locations

KR (1)