NCT03019562

Brief Summary

Oxycodone is one of the most widely used opioids for pain treatment. Many studies demonstrated good efficacy of oxycodone on postoperative pain. In this study, we assess the efficacy and side effects of bolus intravenous of oxycodone injection compared to those of fentanyl in patients after total hip replacement surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

December 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 11, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 12, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 12, 2017

Status Verified

January 1, 2017

Enrollment Period

1 year

First QC Date

January 11, 2017

Last Update Submit

January 11, 2017

Conditions

Pain, Postoperative

Keywords

postoperative pain

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain measurement using Numeric Rating Scale(NRS)

    Measure postoperative pain using NRS at the PostAnesthesia Care Unit(PACU)

    Immediately after surgery

Secondary Outcomes (1)

  • Additional doses of fentanyl for pain management

    From immediately after surgery to 2 days after surgery

Other Outcomes (1)

  • Adverse effect

    From immediately after surgery to 2 days after surgery

Study Arms (2)

Oxycodone

EXPERIMENTAL

4mg of oxycodone iv bolus

Drug: Oxycodone

Fentanyl

ACTIVE COMPARATOR

50ug of fentanyl iv bolus

Drug: Fentanyl

Interventions

OxycodoneDRUG

4mg of oxycodone iv 20 min before the end of surgery, 10ug/kg of fentanyl in Patient-Controlled Analgesia(PCA)

Also known as: Oxynorm
Oxycodone
FentanylDRUG

50ug of fentanyl iv 20 min before the end of surgery, 10ug/kg of fentanyl in Patient-Controlled Analgesia(PCA),

Fentanyl

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • ASA physical status classification I or II
  • Scheduled for total hip replacement surgery

You may not qualify if:

  • Allergic to study drugs
  • Patient with asthma or COPD, patient who is severely respiratory depressed
  • Renal of hepatic insufficiency
  • Epileptic status
  • Intracranial lesion associated with increased intracranial pressure
  • Acute abdomen, patient who has diagnosed paralytic ileus or suspicious ileus
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyung Hee University Hospital

Seoul, 02447, South Korea

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

OxycodoneFentanyl

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

CodeineMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsPiperidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Mi Kyeong Kim, MD, PhD

    Kyunghee University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Youngsoon Kim, MD, PhD

CONTACT

+82-2-958-8598ys.kim@khu.ac.kr

Hee Yong Kang, MD

CONTACT

+82-2-958-8589ujuabba@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 11, 2017

First Posted

January 12, 2017

Study Start

December 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

January 12, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)