Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00474110
Status:
WITHDRAWN
Last Update Posted:
2010-11-01
First Post:
2007-05-14
Brief Title:
Ketamine and Hydromorphone for Patient Controlled Pain Relief in Childrens Mucositis
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Ketamine and Hydromorphone PCA Analgesia for Antineoplastic-Induced Pediatric Mucositis
Status:
WITHDRAWN
Status Verified Date:
2010-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Clinical practice had changed between time of initial protocol development and subject recruitment We were not able to find eligible patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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
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
Detailed Description:
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 consentingassenting 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 fellowstaff 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 mcgkghour 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 fellowstaff 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 importantA 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 05 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 02 and K 02 mgmL 11 - 20 mg20 mg in 100 mL Solution 2 medium HM 02 and K 06 mgmL 13 - 20 mg60 mg in 100 mL Solution 3 high HM 02 and K 1 mgmL 15 - 20 mg100 mg in 100 mL
The starting solution will be Solution 2 in a minimum dose 4 mcgkghour of hydromorphone HM and 12 mcgkghour of ketamine K 002 mLkghour of solution
Add background 4 mcgkghour of Hydromorphone equivalent 002 mLkghour of solution may occur once as required after solution change criteria are met
Increase background additional 4 mcgkghour of Hydromorphone equivalent 002 mLkghour of solution
Repeat Increase background 4 mcgkghour of Hydromorphone equivalent 002 mLkghour of solution may occur 3 hourly as required after solution change criteria are met
Decrease background decrease by 4 mcgkghour of Hydromorphone equivalent 002 mLkghour of solution may occur 3 hourly as required after solution change criteria are met
Stop background Background is stopped so that only bolus dose remains May occur when background has been reduced to 4 mcgkghour of Hydromorphone for at least 3 hours or exceessive ADEs
DC 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 patientfamily 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
An open-label study of 20 consecutive consentingassenting 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 fellowstaff 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 mcgkghour 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 fellowstaff 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 importantA 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 05 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 02 and K 02 mgmL 11 - 20 mg20 mg in 100 mL Solution 2 medium HM 02 and K 06 mgmL 13 - 20 mg60 mg in 100 mL Solution 3 high HM 02 and K 1 mgmL 15 - 20 mg100 mg in 100 mL
The starting solution will be Solution 2 in a minimum dose 4 mcgkghour of hydromorphone HM and 12 mcgkghour of ketamine K 002 mLkghour of solution
Add background 4 mcgkghour of Hydromorphone equivalent 002 mLkghour of solution may occur once as required after solution change criteria are met
Increase background additional 4 mcgkghour of Hydromorphone equivalent 002 mLkghour of solution
Repeat Increase background 4 mcgkghour of Hydromorphone equivalent 002 mLkghour of solution may occur 3 hourly as required after solution change criteria are met
Decrease background decrease by 4 mcgkghour of Hydromorphone equivalent 002 mLkghour of solution may occur 3 hourly as required after solution change criteria are met
Stop background Background is stopped so that only bolus dose remains May occur when background has been reduced to 4 mcgkghour of Hydromorphone for at least 3 hours or exceessive ADEs
DC 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 patientfamily 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None