Ketamine and Hydromorphone for Patient Controlled Pain Relief in Children's Mucositis

NCT00474110 | Withdrawn Phase 3

• 1 other identifier: H06-03799
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The treatment of cancer in children may result in an extremely painful condition called oral mucositis when the cells lining the mouth are injured due to the cancer medication. Patients with this condition are often unable to take anything by mouth or to swallow their own saliva. This severe pain may last for as long as 2 weeks. A survey of our previous 22 patients showed high daily pain scores despite the use of intravenous (given through a small tube in a vein) opioid medications (family of pain relieving drugs, e.g. morphine and hydromorphone). The purpose of this pilot study is to determine which of 3 concentrations of ketamine to combine with hydromorphone to provide the best pain relief with minimum side effects. The results from this study will allow us to do a larger study to compare the best concentration found from this study to standard treatment. If successful, this combination of ketamine and hydromorphone will also be used to treat other pain problems in children.

Conditions

Mucositis

Keywords

Ketamine; hydromorphone; pediatric mucositis

Outcome Measures

Primary Outcomes (1)

• 24 hour hydromorphone consumption

Secondary Outcomes (1)

• Self-report symptom scores

Study Arms (1)

1

EXPERIMENTAL

Ketamine and hydromorphone for patient-controlled relief in children's mucositis.

Drug: Ketamine & hydromorphone

Interventions

Ketamine & hydromorphone DRUG

See Detailed Description

1

Eligibility Criteria

• Age: 5 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pediatric oral mucositis due to anti-neoplastic therapy.

You may not qualify if:

• Must not be receiving concurrent oral analgesics or sedatives such as acetaminophen, gabapentin, lorazepam, nabilone or clonidine.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

BC Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

MeSH Terms

Conditions

Mucositis

Interventions

Ketamine; Hydromorphone

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Carolyne Montgomery, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Mark Ansermino, MD

  University of British Columbia

  STUDY DIRECTOR

• Caron Strahlendorf, MD

  University of British Columbia

  STUDY DIRECTOR

• Robert Purdy, MD

  University of British Columbia

  STUDY DIRECTOR

• Colleen Court, MD

  University of British Columbia

  STUDY DIRECTOR

• Joanne Lim

  University of British Columbia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 14, 2007
• First Posted: May 16, 2007
• Study Start: August 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: November 1, 2010

Record last verified: 2010-10

Locations

CA (1)