NCT00385541

Brief Summary

Both morphine and hydromorphone are pain medications commonly used after surgery. It is thought at the institution that hydromorphone causes less side effects but this has not been studied. The study proposes to treat the patients with either morphine or hydromorphone and determine how much nausea, vomiting, and itching they have with each drug

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2003

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

November 1, 2003

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2006

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

August 31, 2010

Completed
Last Updated

August 14, 2018

Status Verified

July 1, 2018

Enrollment Period

3.9 years

First QC Date

October 5, 2006

Results QC Date

July 14, 2010

Last Update Submit

July 16, 2018

Conditions

Post Operative Pain

Keywords

painmorphinehydromorphonenauseavomitingpruritis

Outcome Measures

Primary Outcomes (1)

  • Nausea Assessment by Patient

    Nausea scale range: (0 = none, 10 = the worst), ordinal.

    1 hour after surgery, 8 hours after surgery

Secondary Outcomes (4)

  • Mean Score on the Numeric Rating Scare (NRS) Pruritus Scale

    1 hour after surgery, 8 hours after surgery

  • Pain Assessment by Patient

    1 hour after surgery, 8 hours after surgery

  • The Number of Patients Who Vomited

    1 hour after surgery, 8 hours after surgery

  • Mean Score on the Ramsey Scale of Sedation

    1 hour after surgery, 8 hours after surgery

Study Arms (2)

A

ACTIVE COMPARATOR

Patients receive morphine 1mg/dose PCA for postsurgical pain; max 10 mg/hr; lockout 6 minutes.

Drug: Morphine PCA

B

ACTIVE COMPARATOR

Patients receive hydromorphone 0.2mg/dose PCA for postsurgical pain; max 10mg/hr; lockout 6 minutes.

Drug: Hydromorphone PCA

Interventions

Morphine PCADRUG

Morphine 1mg/mL, dose 1mL, lockout 6 minutes, max 10mL

Also known as: Astramorph PF, Duramorph, Infumorph
A
Hydromorphone PCADRUG

hydromorphone PCA 0.2mg/lml, dose 1ml, lockout 6min, max 10ml

Also known as: Dilaudid
B

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients scheduled for abdominal surgery requiring post-operative PCA
  • ASA = I or II

You may not qualify if:

  • preoperative pain or use of pain medication
  • narcotic allergy
  • morbid obesity (Body Mass Index \> 30)
  • diagnosis of sleep apnea
  • hepatic or renal disease
  • use of medications that would affect narcotic pharmacodynamics
  • preoperative nausea, vomiting, or pruritis
  • diagnosis of alcoholism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia Presbyterian Hospital

New York, New York, 10032, United States

Location

Related Publications (1)

  • Hong D, Flood P, Diaz G. The side effects of morphine and hydromorphone patient-controlled analgesia. Anesth Analg. 2008 Oct;107(4):1384-9. doi: 10.1213/ane.0b013e3181823efb.

    PMID: 18806056RESULT

MeSH Terms

Conditions

Pain, PostoperativePainNauseaVomitingPruritus

Interventions

MorphineHydromorphone

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsSigns and Symptoms, DigestiveSkin DiseasesSkin and Connective Tissue DiseasesSkin Manifestations

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Limitations and Caveats

This was a small study under typical clinical conditions.

Results Point of Contact

Title
Dr. Pamela Flood
Organization
Columbia University
pflood@stanford.edu
201-370-3933

Study Officials

  • Pamela Flood, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
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
Professor of Anesthesiology

Study Record Dates

First Submitted

October 5, 2006

First Posted

October 9, 2006

Study Start

November 1, 2003

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

August 14, 2018

Results First Posted

August 31, 2010

Record last verified: 2018-07

Locations

US(1)