NCT00892606

Brief Summary

The investigators propose to compare analgesia by methadone and ketamine with a combination of morphine and ketamine in orthopedic surgery patients with moderate to severe pain. The investigators hypothesize that when given with ketamine before surgical incision, methadone is more effective than morphine in reducing postoperative morphine consumption and reducing pain during movement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_4

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

January 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 4, 2009

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

May 17, 2017

Completed
Last Updated

June 14, 2017

Status Verified

May 1, 2017

Enrollment Period

4.9 years

First QC Date

April 30, 2009

Results QC Date

April 6, 2017

Last Update Submit

May 16, 2017

Conditions

FracturePain, Postoperative

Keywords

Surgery, OrthopedicPain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • Opioid Consumption During the 48 Hours After Surgery

    The amount of opioid required for postoperative pain relief

    48 hours

Secondary Outcomes (2)

  • Number of Participants With Post Operative Nausea and Vomiting

    48 hours

  • Visual Pain Score

    48 hours

Study Arms (2)

Methadone

EXPERIMENTAL

Patients received 2 µg/kg fentanyl, 0.2 mg/kg ketamine and 0.2 mg/kg of methadone IV with induction of general anesthesia.

Drug: Methadone

Control

ACTIVE COMPARATOR

Patients received 2 µg/kg fentanyl, 0.2 mg/kg ketamine, and 0.2 mg/kg morphine (standard of care)

Drug: Morphine

Interventions

MethadoneDRUG

Patients will receive 0.2 mg/kg of methadone IV immediately after intubation

Also known as: Symoron, Dolophine, Amidone, Methadose, Physeptone, Heptadon, 6-(Dimethylamino)-4,4-diphenylheptan-3-one (IUPAC name)
Methadone
MorphineDRUG

Patients will receive 0.2 mg/kg of morphine IV immediately after intubation

Also known as: Opiate, (5α,6α)-7,8-didehydro-4,5-epoxy-17-methylmorphinan-3,6-diol
Control

Eligibility Criteria

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

You may qualify if:

  • ASA I-III
  • Ages 18-65 years
  • Presenting for lower extremity orthopedic surgery involving fracture of long bones at University of Louisville Hospital
  • Surgery expected to last more than one hour
  • Patient expected to have moderate to severe post-operative pain
  • Patient refused regional anesthesia or has a contraindication to regional anesthesia

You may not qualify if:

  • Any known contraindications to methadone including hypothyroidism, Addison's disease, prostatic hypertrophy, or urethral stricture.
  • Difficulty or inability to understand the study or protocol
  • Known renal or hepatic dysfunction
  • BMI\> 35
  • Known respiratory or cardiovascular problems, such as obstructive sleep apnea or oxygen saturation of less than 92% on room air
  • Taking any of the known drugs that induce or inhibit the cytochrome p450 enzyme systems. Common examples of these drugs are antifungal, antiretroviral, barbiturates, dexamethasone, and macrolide antibiotics.
  • Pregnancy
  • Taking preoperative opioids for more than 2 weeks before the surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

Location

Related Publications (1)

  • Wadhwa A, Clarke D, Goodchild CS, Young D. Large-dose oral dextromethorphan as an adjunct to patient-controlled analgesia with morphine after knee surgery. Anesth Analg. 2001 Feb;92(2):448-54. doi: 10.1097/00000539-200102000-00032.

    PMID: 11159249BACKGROUND

MeSH Terms

Conditions

Fractures, BonePain, Postoperative

Interventions

MethadoneMorphineOpiate Alkaloids

Condition Hierarchy (Ancestors)

Wounds and InjuriesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

KetonesOrganic ChemicalsMorphine DerivativesMorphinansAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Results Point of Contact

Title
Nancy Alsip
Organization
University Louisville
nlalsi01@exchange.louisville.edu
502-852-2905

Study Officials

  • Anupama Wadhwa, MD

    University of Louisville

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

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
SPONSOR

Study Record Dates

First Submitted

April 30, 2009

First Posted

May 4, 2009

Study Start

January 1, 2009

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

June 14, 2017

Results First Posted

May 17, 2017

Record last verified: 2017-05

Locations

US(1)