NCT02243254

Brief Summary

Postoperative hyperalgesia has been reported after intraoperative administration of small or high-dose remifentanil. Cyclooxygenase inhibitor exhibit preventive effects on the development of opioid-induced hyperalgesia. The aim of this study is to evaluate the preventive effect of intravenous ibuprofen (Caldolor®) on remifentanil-induced hyperalgesia

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 17, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Last Updated

November 18, 2015

Status Verified

November 1, 2015

Enrollment Period

9 months

First QC Date

September 15, 2014

Last Update Submit

November 16, 2015

Conditions

IbuprofenRemifentanilHyperalgesiaPain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • cumulative morphine consumption

    cumulative patient-controlled analgesia (PCA) morphine consumption

    postoperative 48 hours

Secondary Outcomes (1)

  • Pain score

    postoperative 1, 3, 6,12, 24, 48 hours Pain score

Study Arms (4)

high dose remifentanil without ibuprofen

PLACEBO COMPARATOR

remifentanil target-controlled infusion effect-site concentration 4 ng/ml normal saline before surgical incision

Drug: high dose remifentanil

low dose remifentanil without ibuprofen

PLACEBO COMPARATOR

remifentanil target-controlled infusion effect-site concentration 1 ng/ml normal saline before surgical incision

Drug: low dose remifentanil

high dose remifentanil with ibuprofen

ACTIVE COMPARATOR

remifentanil target-controlled infusion effect-site concentration 4 ng/ml Intravenous ibuprofen 800 mg before surgical incision

Drug: high dose remifentanilDrug: Ibuprofen

low dose remifentanil with ibuprofen

ACTIVE COMPARATOR

remifentanil target-controlled infusion effect-site concentration 1 ng/ml Intravenous ibuprofen 800 mg before surgical incision

Drug: IbuprofenDrug: low dose remifentanil

Interventions

high dose remifentanilDRUG

high dose remifentanil

high dose remifentanil with ibuprofenhigh dose remifentanil without ibuprofen
IbuprofenDRUG

intravenous ibuprofen

high dose remifentanil with ibuprofenlow dose remifentanil with ibuprofen
low dose remifentanilDRUG

low dose remifentanil

low dose remifentanil with ibuprofenlow dose remifentanil without ibuprofen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients scheduled for elective pancreaticoduodenectomy

You may not qualify if:

  • Patients with chronic pain
  • Patients with psychiatric disease
  • Patients with nonsteroidal antiinflammatory drugs allergy
  • Patients with renail dysfunction
  • History of drug addiction
  • Pregnant patient
  • Inability to use a PCA device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

HyperalgesiaPain, Postoperative

Interventions

RemifentanilIbuprofen

Condition Hierarchy (Ancestors)

Somatosensory DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesPain

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhenylpropionatesAcids, Carbocyclic

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2014

First Posted

September 17, 2014

Study Start

July 1, 2014

Primary Completion

April 1, 2015

Last Updated

November 18, 2015

Record last verified: 2015-11

Locations

KR(1)