Condition category
Signs and Symptoms
Date applied
01/12/2013
Date assigned
12/12/2013
Last edited
19/06/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
We are carrying out a study on patients undergoing negative pressure wound therapy dressing changes. Common analgesics (painkillers) such as local anesthesia with lidocaine alone are often not effective for this procedure. Opioids are the most effective analgesics but their use is limited by numerous side effects, such as nausea, vomiting, constipation, urinary retention, dysphoria (an emotional state characterized by anxiety, depression or unease), euphoria (a feeling or state of intense excitement and happiness), altered cognitive (mental) function and hypoventilation (slow breathing). Other sedatives used for procedural sedation such as propofol or benzodiazepines offer no analgesia (pain relief) and may cause hypoventilation, alterations in hemodynamics and drowsiness. Ketamine is an old anaesthetic agent that also has analgesic properties. Ketamine also reduces the need for opioids and thus helps to reduce side effects caused by opioid medication.

Who can participate?
Adult patients aged over 18 undergoing elective wound dressing changes in the plastic surgery unit. 23 patients will be enrolled in the study.

What does the study involve?
The wound dressing changes will take place every 3-4 days for each patient. Each patient will be randomly allocated to receive either S-ketamine or saline on their first procedure and then on the second procedure the patient will be given the remaining medicine. Each patient will be given midazolam as a premedication before the procedure and a solution containing lidocaine with saline. If the pain is too great during the procedure, the patient will be given fentanyl as a rescue medication.

What are the possible benefits and risks of participating?
The possible benefits of participating in the study are improved analgesia during the procedure, reduced need for rescue medication (fentanyl) and fewer side effects caused by opioid medication. Possible risks are the side effects caused by ketamine. The most common side effect of ketamine is altered mental state. However, that can be prevented by giving midazolam as a premedication.

Where is the study run from?
The study is run from the Helsinki University Central Hospital Töölö Hospital, Finland.

When is the study starting and how long is it expected to run for?
It is anticipated that recruitment for the study will start in April 2014. Participants will be enrolled on the study for a period of one year, recruiting the last patient on April 2015. However, the recruitment period will be extended if necessary until 23 patients are enrolled.

Who is funding the study?
Helsinki University Central Hospital, Finland.

Who is the main contact?
Docent Vesa Kontinen
Dr. Elina Jokinen

Trial website

Contact information

Type

Scientific

Primary contact

Dr Elina Brinck

ORCID ID

Contact details

Helsinki University Central Hospital
Töölö Hospital
Topeliuksenkatu 5
PB 266
Helsinki
00029
Finland

Additional identifiers

EudraCT number

2013-005114-35

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

S-ketamine to reduce negative pressure wound therapy dressing change associated pain: a prospective, randomized, blinded cross-over study

Acronym

KETAPLAST

Study hypothesis

S-ketamine effectively alleviates procedural pain and reduces the need for rescue medication (fentanyl) during negative pressure wound therapy dressing change compared to local anaesthesia.

Ethics approval

Operative ethics committee of the Helsinki University Central Hospital, 12t/02/2014, ref: 38/13/03/02/2014

Study design

Prospective randomized blinded cross-over study

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Procedural pain related to negative pressure wound therapy dressing changes

Intervention

1. Intervention group: S-ketamine dose 0.25 mg/kg will be administered during negative pressure wound therapy dressing change in addition to local anaesthesia
2. Control group: placebo (saline)

The wound dressing changes will take place every 3-4 days for each patient. Each patient will be randomized to receive either S-ketamine or saline on their first procedure and then on the second procedure, she or he will be given the remaining medicine. Each patient will be given midazolam as a premedication before the procedure and a solution containing Lidocaine 1% with saline will be absorbed into the tissue treated. If the pain score (NRS scale) exceeds 5 during the procedure, she or he will be given fentanyl 0.5-1 ug/kg as a rescue medication.

Intervention type

Drug

Phase

Not Applicable

Drug names

S-ketamine

Primary outcome measures

1. Pain measured using the NRS scale during the procedure, at the end of the procedure, and at three months after the procedure
2. Possible need for rescue medicine (fentanyl) during the procedure and, if needed, how much

Secondary outcome measures

To evaluate and compare the possible side effects such as altered mental state, desaturation, changes in blood pressure and heart rate associated with the treatment of S-ketamine or rescue medication (fentanyl):
1. Confusion measured with Richmond Agitation Sedation Scale (RASS) at 30 minutes and 60 minutes after the drug investigated (S-ketamine or placebo) has been given
2. Saturation with pulse oximetry (SpO2 %) at 15 minutes, 30 minutes and 60 minutes after the drug investigated (S-ketamine or placebo) has been given
3. Hemodynamic parameters (blood pressure mmHg and pulse beats/minute) at 15 minutes, 30 minutes and 60 minutes after the drug investigated (S-ketamine or placebo) has been given

Overall trial start date

01/04/2014

Overall trial end date

31/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Adult patients over 18 years undergoing elective negative pressure wound therapy wound dressing changes in the plastic surgery unit

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

23

Participant exclusion criteria

1. Body mass index over 35
2. Unstable ischaemic cardiac disease
3. Increased intracranial pressure
4. Increased intraocular pressure
5. Gravidity
6. Lactation
7. Hypersensitivity or allergy to ketamine, fentanyl or midazolam
8. Severe psychiatric disease
9. Inability to use the Numerical Rating Scale (NRS) pain scale

Recruitment start date

01/04/2014

Recruitment end date

01/04/2015

Locations

Countries of recruitment

Finland

Trial participating centre

Helsinki University Central Hospital
Helsinki
00029
Finland

Sponsor information

Organisation

Helsinki University Central Hospital (Finland)

Sponsor details

c/o Vesa Kontinen
Jorvi Hospital
Turuntie 150
PB 800
Helsinki
00029
Finland

Sponsor type

Hospital/treatment centre

Website

http://www.hus.fi/en/Pages/default.aspx

Funders

Funder type

Hospital/treatment centre

Funder name

Helsinki University Central Hospital (Finland)

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