Condition category
Signs and Symptoms
Date applied
26/01/2011
Date assigned
07/02/2011
Last edited
07/02/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Publication citations

Additional files

Editorial Notes