Prospective, double-blind, randomised study of the efficacy of ketamine for oropharyngeal mucositis pain
Monash Health
60 participants
Feb 11, 2019
Interventional
Conditions
Summary
This study looks at the effectiveness of a new treatment for cancer therapy-related oropharyngeal mucositis (throat or mouth ulceration) pain. Who is it for? You may be eligible for this study if you are aged 18 or over and have cancer treatment-related oropharyngeal mucositis (throat or mouth ulceration) pain. Study details This is a randomised controlled research project, meaning that patients will be assigned by chance to either the experimental arm to receive midazolam and ketamine, or to the control arm to receive midazolam alone. This is also a blinded study, meaning that study doctors and patients will not know which group a patient has been assigned to until the end of the study. Participants in both groups will receive medication through a needle in the arm for up to 5 days. All participants will provide blood samples and answer questionnaires. It is hoped this research will demonstrate ketamine is an effective drug in treating mucositis pain, and this treatment may then be offered to all suitable patients who are also experiencing mucositis pain.
Eligibility
Inclusion Criteria3
- Treatment related oral or pharyngeal mucositis with average pain score of >/= 4 on the Brief Pain Inventory (BPI)
- Males and females aged over 18 years.
- Able to provide informed consent and complete questionnaires.
Exclusion Criteria17
- Patients in who significant hypertension or tachycardia would be potentially dangerous.
- Patients who have previously received ketamine for chronic pain by any route of administration prior to the study within the preceding six months will be excluded. Patients who have received ketamine for an anaesthetic indication, will not be excluded.
- Patients who have undergone any other procedure or therapy likely to affect pain during the study period.
- Patients with recent seizures or a history of uncontrolled epilepsy not related to the underlying malignancy.
- Patients with a documented history of uncontrolled hypertension, cardiac arrhythmias, cardiac failure, ischaemic heart disease or recent history of cerebral vascular accident, cerebral trauma, intracerebral mass or haemorrhage.
- Patients with a documented history of increased intraocular pressure such as glaucoma.
- Patients with a known serious psychiatric illness such as schizophrenia, acute psychosis excluding depression and anxiety.
- Patients with a documented history of acute intermittent porphyria.
- Patients with a documented history of uncontrolled hyperthyroidism. (Patients receiving thyroid replacement must have a thyroid stimulating hormone (TSH) serum level within the normal range).
- Patients currently taking prohibited drugs such as rifampicin, carbamazepine, phenytoin and diazepam.
- Patients currently taking monoamine oxidase inhibitors (MAOIs) or who have been taking non-reversible monoamine oxidase inhibitors within 4 weeks prior to study entry or reversible MAOIs within 2 days of study entry.
- Patients who have participated in a clinical study of a new chemical entity within the last month, prior to study entry.
- Any patient who has had an adverse reaction to ketamine in the past.
- Comorbidities contraindicating the use of ketamine.
- Severe organ dysfunction.
- Pregnancy and lactation.
- All participants are required to use an effective form of contraception.
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Interventions
The purpose of the proposed study is to determine the effectiveness of ketamine, for managing cancer treatment-related (chemotherapy, radiotherapy, targeted therapy, immunotherapy, or haematological treatments) oropharyngeal mucositis pain. This prospective, double-blind, randomised study will see participants randomised to one of two study arms; 1. Intervention Arm: Continuous subcutaneous infusion (CSCI) of ketamine with 5mg midazolam. The dosing schema is as follows; Day 1: 100mg ketamine with 5mg midazolam via CSCI over 24 hours. If pain remains uncontrolled then the dose is escalated to; Day 2: 200mg ketamine with 5mg midazolam via CSCI over 24 hours. If pain remains uncontrolled then the dose is escalated to; Day 3: 300mg ketamine wih 5mg midazolam via CSCI over 24 hours. The ketamine infusion is maintained at the effective or maximal dose for 72 hours. 2: Active Control: 5mg midazolam via CSCI over 24 hours. The effectiveness of the intervention will be assessed by; ? Clinically improvement in average pain of >/= 2 Brief Pain Inventory (BPI: Appendix A) units in the absence of more than four breakthrough doses of analgesia over the previous 24 hours. ? Analgesic requirements reduction of 50% or greater in 24-hour opioid dose, or a 50% or greater reduction in the number of opioid breakthrough doses. ? Improvement in oral intake at the end of the 5-day study period.
Locations(4)
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ACTRN12619000108112