Ketamine plus morphine versus morphine alone for analgesic titration in the postoperative care unit

ISRCTN	ISRCTN69274618
DOI	https://doi.org/10.1186/ISRCTN69274618
Protocol serial number	N/A
Sponsor	IPS Universitaria (Colombia) - Clinica Leon XIII
Funder	IPS Universitaria (Colombia) - Clinica Leon XIII

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

76 Stuart Street
Kingston General Hospital
Department of Anesthesia
Kingston
K7L 2V7
Canada

Phone	+1 613 985 0424
Email	luisdr74@yahoo.com

Study information

Primary study design	Interventional
Study design	Interventional randomised (computer generated) active controlled double blinded (participants + outcomes assessors) parallel multicentre trial
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Phase IV
Drug / device / biological / vaccine name(s)	Ketamine, morphine
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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.
Completion date	01/04/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	132
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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes