NCT00330343

Brief Summary

This is an investigator initiated dose finding study designed to determine the optimal dose of naloxone to prevent or minimize the most common side effects induced by opioids, namely itching, nausea, and vomiting. Male and female inpatients of the Children's Center of the Johns Hopkins Hospital, who are greater than 6 and less than 18 years of age with acute, moderate to severe pain, and who are to be treated with intravenous Patient controlled analgesia (IVPCA) morphine will be eligible for inclusion in this study. Patients will be recruited by a study investigator prior to the initiation of IVPCA therapy. The majority of patients will be post operative patients, and will start therapy and the investigational drug in the Post Anesthesia Care Unit or the Pediatric Intensive Care Unit. The investigators plan on studying between 10 and 99, male and female patients over a 2 year period.

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_2 pain

Timeline
Completed

Started May 2004

Longer than P75 for phase_2 pain

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

May 1, 2004

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 24, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 26, 2006

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
8.1 years until next milestone

Results Posted

Study results publicly available

July 19, 2017

Completed
Last Updated

July 19, 2017

Status Verified

July 1, 2017

Enrollment Period

5.1 years

First QC Date

May 24, 2006

Results QC Date

April 10, 2012

Last Update Submit

July 18, 2017

Conditions

PainNauseaPruritus

Keywords

morphinenaloxonepediatricsadverse effectspain

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Naloxone Side Effects

    incidence of nausea, vomiting, pruritus following naloxone infusion

    0-48 hours after infusion begins

Study Arms (1)

Naloxone

EXPERIMENTAL

continuous infusion of naloxone administered in escalating dosing from 0.05 mcg/kg/hr to 1.65 mcg/kg/hour

Drug: naloxone

Interventions

naloxoneDRUG

continuous infusion of naloxone administered in escalating dosing from 0.05 mcg/kg/hr to 1.65 mcg/kg/hour

Naloxone

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Male and female patients greater than 6 and less than 18 years of age with acute, moderate to severe pain who are to start treatment with IVPCA morphine as inpatients of the Children's Center of the Johns Hopkins Hospital

You may not qualify if:

  • patients who require concomitant benzodiazepine administration
  • allergic to opioids
  • have been in an investigational drug trial within 1 month
  • received opioids with in 7 days of the study
  • parent with psychiatric illness which impairs their ability to provide consent parent who does not speak English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

John Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (2)

  • Maxwell LG, Kaufmann SC, Bitzer S, Jackson EV Jr, McGready J, Kost-Byerly S, Kozlowski L, Rothman SK, Yaster M. The effects of a small-dose naloxone infusion on opioid-induced side effects and analgesia in children and adolescents treated with intravenous patient-controlled analgesia: a double-blind, prospective, randomized, controlled study. Anesth Analg. 2005 Apr;100(4):953-958. doi: 10.1213/01.ANE.0000148618.17736.3C.

    PMID: 15781505BACKGROUND

  • Gan TJ, Ginsberg B, Glass PS, Fortney J, Jhaveri R, Perno R. Opioid-sparing effects of a low-dose infusion of naloxone in patient-administered morphine sulfate. Anesthesiology. 1997 Nov;87(5):1075-81. doi: 10.1097/00000542-199711000-00011.

    PMID: 9366459BACKGROUND

MeSH Terms

Conditions

PainNauseaPruritus

Interventions

Naloxone

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveSkin DiseasesSkin and Connective Tissue DiseasesSkin Manifestations

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Myron Yaster
Organization
JHU
myaster1@jhmi.edu
9552393

Study Officials

  • Myron Yaster, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2006

First Posted

May 26, 2006

Study Start

May 1, 2004

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

July 19, 2017

Results First Posted

July 19, 2017

Record last verified: 2017-07

Locations

US(1)