Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
KirKipu09-1
Study information
Scientific title
The effect of pregabalin on post-operative pain and recovery after kidney transplantation: a double blind, randomised, active-placebo controlled parallel-group clinical trial
Acronym
Study hypothesis
Premedication with pregabalin will reduce post-operative pain after kidney transplantation.
Ethics approval
Helsinki University Central Hospital (Helsingin ja Uudenmaan sairaanhoitopiiri) Ethics Committee approved on the 14th October 2009
Study design
Double blind randomised active-placebo controlled parallel-group phase IV clinical 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 use the contact details below to request a patient information sheet
Condition
Postoperative pain
Intervention
Treatment arm: single dose of pregabalin (150 mg if body weight 40 - 80 kg and 300 mg if body weight 80 - 120 kg) orally as premedication 1 hour before entering operating suite.
Control arm: single dose of diazepam (7.5 mg if body weight 40 - 80 kg and 15 mg if body weight 80 - 120 kg) orally as premedication 1 hour before entering operating suite.
Follow-up 14 days after the operation in both arms.
Intervention type
Drug
Phase
Phase IV
Drug names
Pregabalin
Primary outcome measure
PCA opioid (oxycodone) consumption 24 after the operation
Secondary outcome measures
1. Patient-reported pain in rest and movement, type of movement provoking pain, dizziness, tiredness, nausea and vomiting, bladder irritation, bowel movements, self-reported overall ability and mood, measured every 12 hours from the first post-operative day to 14 days after the operation
2. Assessment of sedation and anxitety when entering operating suite (1 hour after drug administration)
3. Assessment of pain, bladder irritation, nausea and vomiting, dizziness and sedation and patient-reported symptoms measured at 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 240 minutes and 6 and 8 hours after the end of the operation
4. Bowel function and kidney function
5. Blood sample for measurement of plasma pregabalin concentration taken at 2, 8, 16 and 24 hours after drug administration
Overall trial start date
01/04/2010
Overall trial end date
31/12/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients receiving allogenic kidney transplant from a brain-dead donor volunteering to
participate
2. Male and female, over 18 years, no study-related upper age limit (but very old persons are usually not accepted as recipients for a kidney transplant)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
140
Participant exclusion criteria
1. Chronic opioid or gabapentinoid treatment
2. Unable to communicate in Finnish or Swedish language
3. Krooninen opioidilääkitys
4. Unable to use PCA
5. Unable to use NRS (numeral rating scale) for pain assessment
6. Allergy to pregabalin, oxycodone, propofol or remifentanil
7. Body weight less than 40 kg or greater than 120 kg
Recruitment start date
01/04/2010
Recruitment end date
31/12/2011
Locations
Countries of recruitment
Finland
Trial participating centre
Helsinki University Central Hospital
Helsinki
FI-00029 HUS
Finland
Funders
Funder type
Hospital/treatment centre
Funder name
Helsinki University Central Hospital (Finland) - research funds
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
Basic results (scientific)
Publication list