Ketamine plus morphine versus morphine alone for analgesic titration in the postoperative care unit
| ISRCTN | ISRCTN69274618 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69274618 |
| Secondary identifying numbers | N/A |
- Submission date
- 26/01/2011
- Registration date
- 07/02/2011
- Last edited
- 07/02/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Luis Enrique Chaparro
Scientific
Scientific
76 Stuart Street
Kingston General Hospital
Department of Anesthesia
Kingston
K7L 2V7
Canada
| Phone | +1 613 985 0424 |
|---|---|
| luisdr74@yahoo.com |
Study information
| 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 |
| 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 | Ketamine plus morphine versus morphine alone as a postoperative analgesic titration strategy in adult population: a randomised and double-blinded clinical trial |
| Study acronym | Ketamorphine |
| Study objectives | 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(s) | Comité de Bioética del Instituto de Investigaciones Médicas de la Facultad de Medicina de la Universidad de Antioquia approved on the 29th October 2009 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Ketamine, morphine |
| Primary outcome measure | 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 study start date | 25/03/2010 |
| Completion date | 01/04/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 132 in total (66 in each arm) |
| Key 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) |
| Key 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) |
| Date of first enrolment | 25/03/2010 |
| Date of final enrolment | 01/04/2011 |
Locations
Countries of recruitment
- Canada
- Colombia
Study participating centre
76 Stuart Street
Kingston
K7L 2V7
Canada
K7L 2V7
Canada
Sponsor information
IPS Universitaria (Colombia) - Clinica Leon XIII
University/education
University/education
Carrera 52 #69-16
Medellin
-
Colombia
| anestesia@medicina.udea.edu.co |
Funders
Funder type
University/education
IPS Universitaria (Colombia) - Clinica Leon XIII
No information available
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 |
