Condition category
Cancer
Date applied
08/11/2013
Date assigned
21/11/2013
Last edited
13/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Intractable (unmanageable) cancer pain is a serious health problem when the cancer spreads to the bone. There are options for relieving cancer pain. Conventional painkillers are usually used according to the principles of the World Health Organization. Cancer patients generally develop tolerance to systemic opioids. As conventional pain relief methods do not always relieve intractable cancer pain, researchers are investigating drugs such as ketamine to increase the effectiveness and to decrease their side effects. Ketamine has been recommended to effectively relieve pain patients with chronic pain. Ketamine can also be used as an painkiller for cancer pain. Some studies suggest that another drug, propofol, has pain relief properties, and it has been used as an adjuvant painkiller. We put forward that giving ketamine plus propofol, known as ketofol, may be effective in patients with intractable cancer pain.

Who can participate?
Patients who had intractable cancer pain caused by the cancer spreading to the bone can participate in this study.

What does the study involve?
The patients were randomly allocated to two groups. The control group received a placebo (dummy) fat emulsion and the ketofol group received ketamine plus propofol into their vein. We recorded age, body measurements, heart rate, blood pressure and pain. These measurements were done at the start of the study and at various intervals for 48 hours.

What are the possible benefits and risks of participating?
Patients in the ketofol group may experience a reduction in pain. The side effects include nausea, vomiting, hallucination, double vision, dreaming and nightmares.

Where is the study run from?
The study is run from Ankara Numune Training and Research Hospital, Ankara, Turkey.

When is study starting and how long is it expected to run for?
The study started in December 2009 and is expected to run for 3 months.

Who is funding the study?
Devrek-Dent Private Health Care Limited Company, Turkey.

Who is the main contact?
Dr Derya Gokcinar
dgokcinar@yahoo.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Derya Gokcinar

ORCID ID

Contact details

Yildirim Beyazit Mahallesi
Derman Caddesi
No.17 Kazan
Ankara
Turkey
Ankara
06980
Turkey
+905052283639
dgokcinar@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

B100IEG0110001

Study information

Scientific title

The analgesic effect of ketofol on intractable pain in cancer patients with bone metastasis

Acronym

Study hypothesis

It was hypothesised that Ketofol infusion relieved pain and decreased the supplemental analgesic requirement in patients with intractable cancer pain with bone metastasis. The null hypothesis was that there was no any analgesic effect of ketofol on intractable pain in cancer patients with bone metastasis.

On 13/06/2014 the following changes were made to the trial record:
1. The anticipated start date was changed from 03/12/2012 to 01/12/2009
2. The anticipated end date was changed from 03/07/2013 to 28/02/2010
3. The target number of participants was changed from 85 to 80

Ethics approval

Ethics committee of the Turkish Ministry of Health, Ref: B100IEG0110001

Study design

Prospective double-blind randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please contact kahvecikadriye@gmail.com to request a patient information sheet

Condition

Intractable pain in cancer patients with bone metastasis

Intervention

Based on the dosage of ketamine, propofol and ketofol for the sedation and/or analgesia in the previous studies, we conducted a preliminary study on 20 cancer patients with intractable pain to determine the effective analgesic ketofol dose without performing sedation. We found that the dosage of ketofol including ketamine 5µgkg per min and propofol 5µgkg per min could maintain Ramsey Sedation Score at 2 and the VAS pain score < 4 cm in more than 50% of the subjects.
All patients for analgesia was initially provided via titrating morphine in increments of 3 mg every 5 min until the VAS pain score was < 4 cm. Patients were also given access to a PCA device set to deliver 1mg boluses of IV morphine, with a lockout period of 5 min and no background infusion or limits. The PCA regimen was continued for 48 h. The patients were randomly divided into 2 groups. The control group (n = 36) received intravenous 10% fat emulsion (Intralipid® 10%, Fresenius-kabi Turkey Inc., Istanbul, Turkey) 5µgkg per min over 48 h and the ketofol group (n = 36) received Racemic ketamine (Ketalar®, Pfizer Warner Lambert Turkey Inc., Istanbul, Turkey) 5µgkg per min plus propofol (Propofol 1% Fresenius®, Fresenius-kabi Turkey Inc., Istanbul, Turkey) 5µgkg per min over 48 h. Propofol (150 mg) and ketamine (150 mg) were diluted with 0.9% sodium chloride (150 mL); the concentration of both ketamine and propofol was 1 mgml per min.

Intervention type

Drug

Phase

Not Applicable

Drug names

Ketofol

Primary outcome measures

1. VAS scores were recorded at baseline (after first morphine titration), 1 h, 3 h, 6 h, 12 h, 24 h and 48 h
2. Cumulative morphine consumption (CMC) was recorded at 1 h, 3 h, 6 h, 12 h, 24 h and 48 h after the start of the drugs infusion

Secondary outcome measures

1. Age, gender, weight, height, underlying disease, length of stay in hospital (LOS) measured at baseline
2. Vital status at hospital was evaluated at one month
3. Simplified acute physiology score III (SAPS III) points, and SAPS III predicted mortality (%) were recorded at baseline
4. Heart rate (HR) and mean arterial pressure (MAP) were recorded by an independent investigator at baseline, 5 min, 15 min, 30 min, 1 h, 3 h, 6 h, 12 h, 24 h and 48 h
5. Side effects including nausea, vomiting, hallucination, double vision, dreaming and nightmares were recorded at 48 hours

Overall trial start date

01/12/2009

Overall trial end date

28/02/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Intractable cancer pain caused by bone metastasis
2. Age 18 years or over
3. Recent use of the fentanyl patch
4. Duration of pain being 4 weeks or longer
5. Visual analog scale (VAS) pain intensity score during the previous week ≥ 5 cm (on a scale of 0-10 cm)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

85

Participant exclusion criteria

We excluded the patients with a confirmed or suspected allergy to intravenous fat emulsion, propofol or ketamine

Recruitment start date

01/12/2009

Recruitment end date

28/02/2010

Locations

Countries of recruitment

Turkey

Trial participating centre

Yildirim Beyazit Mahallesi, Derman Caddesi, No.17 Kazan, Ankara, Turkey
Ankara
06980
Turkey

Sponsor information

Organisation

Devrek-Dent Private Health Care Limited Company (Turkey)

Sponsor details

Irmak sokak
No.12/1
Devrek
Zonguldak
67800
Turkey

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Devrek-Dent Private Health Care Limited Company (Turkey)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes