Contact information
Type
Scientific
Primary contact
Dr Luis Enrique Chaparro
ORCID ID
Contact details
76 Stuart Street
Kingston General Hospital
Department of Anesthesia
Kingston
K7L 2V7
Canada
+1 613 985 0424
luisdr74@yahoo.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Ketamine plus morphine versus morphine alone as a postoperative analgesic titration strategy in adult population: a randomised and double-blinded clinical trial
Acronym
Ketamorphine
Study hypothesis
Null hypothesis:
Adding ketamine to a morphine-based analgesic titration scheme does not decrease the morphine request, morphine-related side effects (nausea, vomiting, pruritus, respiratory depression), or time elapsed for adequate pain control (no pain/mild pain), during the staying of patients in the postoperative care unit of a third level hospital.
Alternate hypothesis:
Adding ketamine to a morphine-based analgesic titration scheme decrease the morphine request, morphine-related side effects (nausea, vomiting, pruritus, respiratory depression), or time elapsed for adequate pain control (no pain/mild pain), during the staying of patients in the postoperative care unit of a third level hospital.
Ethics approval
Comité de Bioética del Instituto de Investigaciones Médicas de la Facultad de Medicina de la Universidad de Antioquia approved on the 29th October 2009
Study design
Interventional randomised (computer generated) active controlled double blinded (participants + outcomes assessors) parallel multicentre 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
Post-operative pain
Intervention
Interventional arm:
A 10 cc syringe filled with 10 mg of morphine (1 mg/ml) and 20 mg of ketamine (2 mg/ml) and saline. The patient receives intravenously 2 cc of the solution every 5 minutes until a clinical meaningful response is reached: mild pain or no pain at all. Treatment is administered during the post-operative care unit staying, only.
Control arm:
A 10 cc syringe filled with 10 mg of morphine (1 mg/ml) and saline. The patient receives intravenously 2 cc of the solution every 5 minutes until a clinical meaningful response is reached: mild pain or no pain at all. Treatment is administered during the post-operative care unit staying, only.
The duration of treatment as well as total duration of follow up is limited to the post-operative care unit staying, which is one hour.
Intervention type
Drug
Phase
Phase IV
Drug names
Ketamine, morphine
Primary outcome measures
1. Pain intensity measured by categorical and numerical (0 = no pain - 10 = unbearable pain) scale at 0, 15, 30, 45 and 60 minutes after start the intervention
2. Cumulative morphine requirement
Secondary outcome measures
1. Cumulated incidence of vomiting (presence/absence)
2. Nausea (presence/absence)
3. Anti-emetic requirement, (yes/no)
4. Pruritus (presence/absence)
5. Sedation (Ramsay Score)
6. Respiratory depression (O2 Sat less than 90 or RR less than 10 or naloxone requirement)
7. Hallucinations (yes/no)
8. Blurred vision (yes/no)
All variables will be measured at 15, 30, 45 and 60 minutes after the beginning of the intervention.
Overall trial start date
25/03/2010
Overall trial end date
01/04/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Adult patients (aged greater than 17 years), either sex
2. Underwent surgery under general anaesthesia
3. State moderate or severe pain (pain intensity greater than 3/10)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
132 in total (66 in each arm)
Participant exclusion criteria
1. Patients older than 80 years
2. Use of any regional analgesic technique (including neuraxial approach)
3. History of opioid or benzodiazepines or ketamine abuse, misuse or addiction
4. Chronic (greater than 3 months) opioid-based analgesic treatment
5. Pregnancy
6. History of a severe psychiatric disorder
7. Morbid obesity (body mass index [BMI] greater than 40 kg/m2)
8. Sleep apnoea
9. Vía aérea difícil (difficult airway)
Recruitment start date
25/03/2010
Recruitment end date
01/04/2011
Locations
Countries of recruitment
Colombia
Trial participating centre
76 Stuart Street
Kingston
K7L 2V7
Canada
Sponsor information
Organisation
IPS Universitaria (Colombia) - Clinica Leon XIII
Sponsor details
Carrera 52 #69-16
Medellin
-
Colombia
anestesia@medicina.udea.edu.co
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
IPS Universitaria (Colombia) - Clinica Leon XIII
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