Ketamine to reduce postoperative pain in back surgery
| ISRCTN | ISRCTN44502774 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44502774 |
| Secondary identifying numbers | KETTO201200074726 |
- Submission date
- 03/10/2012
- Registration date
- 10/10/2012
- Last edited
- 22/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Spinal fusion surgery involves joining together bones in the spine so there is no movement between them. Common analgesics (painkillers) such as paracetamol or non-steroidal anti-inflammatory drugs (NSAIDs) are rarely effective on their own after spinal fusion surgery. Opioids are the most effective analgesics but they have many side effects, such as vomiting and constipation. Ketamine is an old anaesthetic drug that also has analgesic properties. Ketamine reduces the need for opioids after the operation and therefore helps to reduce the side effects caused by opioids. However, the ideal dose of ketamine is not known. The aim of this study is to determine the best dose of ketamine to use to reduce the need for opioids while avoiding side effects.
Who can participate?
Patients aged over 18 undergoing elective posterior lumbar fusion surgery
What does the study involve?
Participants are randomly allocated into three groups. The first group are given placebo (a dummy drug) during the operation. The second and third groups are given different doses of ketamine during the operation. After the operation the participants’ need for opioid medication is recorded.
What are the possible benefits and risks of participating?
Participants treated with ketamine may benefit from improved pain relief (analgesia) after spinal fusion surgery along with fewer side effects caused by opioid medication. Possible risks are side effects caused by ketamine. The most common side effect of ketamine is altered mental state. However, that can be prevented using the drug diazepam.
Where is the study run from?
Helsinki University Central Hospital Töölö Hospital and Pain Clinic (Finland)
When is the study starting and how long is it expected to run for?
January 2013 to December 2014
Who is funding the study?
Helsinki University Central Hospital (Finland)
Who is the main contact?
Dr Elina Jokinen
Contact information
Scientific
Helsinki University Central Hospital
Töölö Hospital
Topeliuksenkatu 5
Helsinki
00251
Finland
Study information
| Study design | Prospective randomized double-blinded placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Administration of S-Ketamine during spinal surgery to reduce postoperative pain |
| Study acronym | KETTO |
| Study objectives | It is known that administration of ketamine during surgery reduces the need of opioid medication in the postoperative period. However, the ideal dose of ketamine is not known. Hypothesis: The more ketamine is being administered during surgery, the greater is the opioid-sparing effect in the postoperative period. However, it is assumed that the number of side effects is also greater. |
| Ethics approval(s) | Valtakunnallinen lääketieteellinen tutkimuseettinen toimikunta TUKIJA, 12/03/2012, ref: 36/06.00.01/2012 |
| Health condition(s) or problem(s) studied | Optimal dose of S-ketamine to reduce the need of opioid medication in the postoperative period |
| Intervention | The study will involve 192 adult patients undergoing elective posterior lumbar fusion surgery. The patienst will be randomized into three groups: 64 patients will be given placebo (NaCl 0,9%), 64 patients will be given an infusion of S-ketamine 2ug/kg/min and 64 patients will be given an infusion of S-ketamine 10ug/kg/min during the surgery. The consumption of oxycodone with PCA-device is being registered 48-hours after the surgery. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Evaluate the effect of different dosages of S-ketamine in the intraoperative period on the need of postoperative opioid medication |
| Secondary outcome measures | Evaluate the postoperative confusion, pain and depression in the different study groups |
| Overall study start date | 01/01/2013 |
| Completion date | 31/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 192 |
| Total final enrolment | 198 |
| Key inclusion criteria | Adult patients (18 years and older) undergoing elective posterior lumbar fusion surgery |
| Key exclusion criteria | 1. BMI>35 2. Unstable ischaemic cardiac disease 3. Increased intracranial pressure 4. Increased intraocular pressure 5. Gravidity 6. Lactation 7. Hypersensivity or allergy to ketamine, oxycodone, propofol or remifentanil 8. Severe psychiatric disease 9. Unwillingness or unability to ude PCA-device 10. Inability to use NRS-pain scale |
| Date of first enrolment | 01/01/2013 |
| Date of final enrolment | 31/12/2014 |
Locations
Countries of recruitment
- Finland
Study participating centre
00251
Finland
Sponsor information
Hospital/treatment centre
c/o Vesa Kontinen
Pain management
Haartmaninkatu 2A
Helsinki
00029
Finland
| Website | http://www.hus.fi/ |
|---|---|
"ROR" |
https://ror.org/02e8hzf44 |
Funders
Funder type
Hospital/treatment centre
Government organisation / Local government
- Alternative name(s)
- Helsinki University Central Hospital, HUS
- Location
- Finland
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 27/02/2019 | No | No | ||
| Results article | results | 01/01/2021 | 22/01/2021 | Yes | No |
Additional files
Editorial Notes
22/01/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
27/02/2019: The basic results of this trial have been uploaded as an additional file
20/07/2016: Plain English summary added.
