Ketamine and Hydromorphone for Patient Controlled Pain Relief in Children's Mucositis
Information source: University of British Columbia
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mucositis
Intervention: Ketamine & hydromorphone (Drug)
Phase: Phase 3
Sponsored by: University of British Columbia
Official(s) and/or principal investigator(s):
Carolyne Montgomery, MD, Principal Investigator, Affiliation: University of British Columbia
Mark Ansermino, MD, Study Director, Affiliation: University of British Columbia
Caron Strahlendorf, MD, Study Director, Affiliation: University of British Columbia
Robert Purdy, MD, Study Director, Affiliation: University of British Columbia
Colleen Court, MD, Study Director, Affiliation: University of British Columbia
Joanne Lim, Study Director, Affiliation: University of British Columbia
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
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.
Official title: Ketamine and Hydromorphone PCA Analgesia for Antineoplastic-Induced Pediatric Mucositis
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 24 hour hydromorphone consumption
Secondary outcome: Self-report symptom scores
The purpose of this observational pilot study is to evaluate the feasibility, efficacy and
optimum ratio of a compounded mixture of HM-K administered parenterally by PCA in pediatric
mucositis patients who have inadequate analgesia using conventional HM PCA.
An open-label study of 20 consecutive consenting/assenting subjects who meet the study
criteria will be conducted. All patients who are eligible for the study will be approached
for informed, written consent and subjects over age 7 will complete an assent form.
The subject will be examined by a pediatric oncology fellow/staff to determine the level of
clinical severity of the mucositis using the Oral Mucositis Assessment Scale (OMAS) and
World Health Organization Mucositis Scale.
A modified Colour Analogue Scale (mCAS) that was originally designed to evaluate pain
intensity will be used to evaluate the self-report symptoms. The subject will then receive
24 hours of therapy using a compounded HM-K PCA solution.
Initial PCA prescription for the Background and Bolus will be set at the existing settings
on the morning of recruitment as per the study entry criteria of minimum hourly use of 4
mcg/kg/hour of HM. The 1-hour Maximum will be set at 4 times the Background dose.
At 24 hours, the 24-hour HM and K consumption will be calculated. The subject will be
re-examined by a pediatric oncology fellow/staff to determine the level of clinical severity
of the mucositis and the self-report symptom evaluation questionnaire administered.
Conventional Therapy of HM PCA will be restarted and at 24 hours, both the mucositis
severity and the self-report symptom evaluation questionnaire administered. Descriptive
summaries of the demographic data will be provided. The 24-hour HM utilization will be
compared to the study entry-level utilization (24 hour period prior to recruitment). A 30%
reduction in opioid use will be considered clinically important. A Symptom Index of Start
Study Symptom Level - End Study Symptom Level / Start Study Symptom level will be calculated
for each symptom including pain intensity. An Index of greater than or equal to 0. 5 will be
considered a positive outcome. Indexes at 0, 24 and 48 hours will be compared. A descriptive
summary of the incidence and treatment of opioid-induced side effects at 0, 24 and 48 hours
will be provided.
Ketamine Solution Concentrations
Solution 1 (low): HM 0. 2 and K 0. 2 mg/mL (1: 1) - 20 mg/20 mg in 100 mL. Solution 2 (medium):
HM 0. 2 and K 0. 6 mg/mL (1: 3) - 20 mg/60 mg in 100 mL. Solution 3 (high): HM 0. 2 and K 1
mg/mL (1: 5) - 20 mg/100 mg in 100 mL.
The starting solution will be Solution 2 in a minimum dose 4 mcg/kg/hour of hydromorphone
(HM) and 12 mcg/kg/hour of ketamine (K) (0. 02 mL/kg/hour of solution.
"Add background": 4 mcg/kg/hour of Hydromorphone equivalent (0. 02 mL/kg/hour of solution)
may occur once as required after solution change criteria are met.
"Increase background": additional 4 mcg/kg/hour of Hydromorphone equivalent (0. 02 mL/kg/hour
Repeat "Increase background": 4 mcg/kg/hour of Hydromorphone equivalent (0. 02 mL/kg/hour of
solution) may occur 3 hourly as required after solution change criteria are met.
"Decrease background": decrease by 4 mcg/kg/hour of Hydromorphone equivalent (0. 02
mL/kg/hour of solution) may occur 3 hourly as required after solution change criteria are
"Stop background": Background is stopped so that only bolus dose remains. May occur when
background has been reduced to 4 mcg/kg/hour of Hydromorphone for at least 3 hours or
"D/C background: Discontinue background HM and only bolus remains.
"Stop Study (SS)": Converting the PCA to conventional HM therapy with any adjuvants required
according to existing practice of Acute Pain Service. For compassionate reasons, if a
patient/family expresses a with to remain on STudy Therapy, this will be accepted.
Once patient has ADEs and requires Solution 1, they may not re-start solution 2 or 3.
Minimum age: 5 Years.
Maximum age: 19 Years.
- Pediatric oral mucositis due to anti-neoplastic therapy.
- Must not be receiving concurrent oral analgesics or sedatives such as acetaminophen,
gabapentin, lorazepam, nabilone or clonidine.
Locations and Contacts
BC Children's Hospital, Vancouver, British Columbia V6H 3V4, Canada
Starting date: August 2009
Last updated: October 29, 2010