NCT01071499

Brief Summary

The purpose of this study is to identify and collect samples from children who have taken a single oral dose of the pain medication morphine, and to determine the genetic differences in the way children metabolize (break down in the body and how it affects them) morphine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for phase_2 pain

Timeline
Completed

Started Mar 2010

Typical duration 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

First Submitted

Initial submission to the registry

February 17, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 19, 2010

Completed
10 days until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

July 5, 2017

Status Verified

May 1, 2017

Enrollment Period

2.7 years

First QC Date

February 17, 2010

Last Update Submit

June 30, 2017

Conditions

Pain

Keywords

pharmacokineticspharmacogeneticsmorphinechildren

Outcome Measures

Primary Outcomes (1)

  • 1 mL blood sample will be obtained at 30, 60, 90, 120, 180 and 240 min after morphine administration.

    4 hours

Secondary Outcomes (1)

  • Face, Legs, Activity, Cry and Consolability (FLACC) pain score

    4 hours

Study Arms (3)

1

ACTIVE COMPARATOR

Subjects recruited will be block assigned to one of the three doses of morphine. Sampling will be done for 4 hrs to determine the key pharmacokinetic parameters.

Drug: Morphine

2

ACTIVE COMPARATOR

Subjects recruited will be block assigned to one of the three doses of morphine. Sampling will be done for 4 hrs to determine the key pharmacokinetic parameters.

Drug: Morphine

3

ACTIVE COMPARATOR

Subjects recruited will be block assigned to one of the three doses of morphine. Sampling will be done for 4 hrs to determine the key pharmacokinetic parameters.

Drug: Morphine

Interventions

MorphineDRUG

One dose of morphine (0.1 mg/kg)

1

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • years of age
  • ASA 1 \& 2 elective surgical patients - Procedures requiring opioid analgesia - Minimal hospital stay of 4 hrs
  • Informed consent

You may not qualify if:

  • Allergy or adverse reaction to morphine
  • Contraindication to morphine analgesia, such as a potential difficult airway -- Abnormal hepatic or renal function known by history or available laboratory results
  • Current regular opioid use
  • Surgical or anesthetic contraindication to oral premedication such as gastro-esophageal reflux disease
  • Children with a BMI of \<10'ile or \>90'ile
  • Declines study participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

British Columbia Children's Hospital-Dept of Anesthesia

Vancouver, British Columbia, V6H 3V4, Canada

Location

Related Publications (1)

  • Velez de Mendizabal N, Jimenez-Mendez R, Cooke E, Montgomery CJ, Dawes J, Rieder MJ, Aleksa K, Koren G, Jacobo-Cabral CO, Gonzalez-Ramirez R, Castaneda-Hernandez G, Carleton BC. A Compartmental Analysis for Morphine and Its Metabolites in Young Children After a Single Oral Dose. Clin Pharmacokinet. 2015 Oct;54(10):1083-90. doi: 10.1007/s40262-015-0256-4.

    PMID: 25773480DERIVED

MeSH Terms

Conditions

Pain

Interventions

Morphine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Carolyne Montgomery, Dr.

    University of British Columbia

    PRINCIPAL INVESTIGATOR

  • Gillian Lauder, Dr.

    University of British Columbia

    STUDY DIRECTOR

  • Katherine Brand, Dr.

    University of British Columbia

    STUDY DIRECTOR

  • Bruce Carleton, Dr.

    University of British Columbia

    STUDY DIRECTOR

  • Gideon Koren, Dr.

    University of British Columbia

    STUDY DIRECTOR

  • Michael Rider, Dr.

    University of British Columbia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

February 17, 2010

First Posted

February 19, 2010

Study Start

March 1, 2010

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

July 5, 2017

Record last verified: 2017-05

Locations

CA(1)