Efficacy of S(+)-Ketamine Administered as a Continuous Infusion for the Control of Postoperative Pain

Postoperative Pain Clinical Trial

Official title:

Efficacy of S(+)-Ketamine Administered as a Continuous Infusion for the Control of Postoperative Pain: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02421913
• Other study ID #: CMCampinas
• Status: Completed
• Phase: Phase 4
• First received: April 16, 2015
• Last updated: April 21, 2015
• Start date: June 2012
• Est. completion date: February 2015

Study information

• Verified date: April 2015
• Source: Centro Medico Campinas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

Background: The use of low-dose continuous infusion of S(+)-ketamine combined with target-controlled intravenous anesthesia with remifentanil and propofol may be related to the control of postoperative pain and of opioid-induced hyperalgesia. The present study aimed to evaluate the efficacy of continuous infusion of S(+)-ketamine given intraoperatively in the control of postoperative pain compared to placebo.

Description:

Methods: This is a double-blind randomized controlled trial with 48 patients of both genders aged from 18 to 65 years who underwent videolaparoscopic cholecystectomy. After venipuncture, patients received intravenous parecoxib sodium (40 mg). Target-controlled intravenous anesthesia was induced with propofol and remifentanil associated with rocuronium and adjusted to maintain the bispectral index between 35 and 50. The S(+)-ketamine group (SG) group received a continuous infusion of S(+)-ketamine at a dose of 0.3mg.kg-1.h-1, while the placebo group (PG) received a continuous infusion of saline at the same dose. Postoperative analgesia was measured by a verbal numerical scale (VNS) from 0 to 10 during 12 hours and treated with morphine when VNS score was equal to or higher than 3 at a dose of 0.05 mg.kg-1 when the patient reported pain for the first time and at a dose of 0.025mg.kg-1 on subsequent occasions. Pain scores were recorded in the postoperative care unit (PACU) and at 4 and 12 hours after the end of the surgery The amount of morphine used during PACU stay, from PACU discharge to 4 hours after surgery, and from 4 to 12 hours after surgery, the overall dose of morphine used, and possible adverse effects were also assessed

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 2015
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 18 Years to 65 Years ASA I and II Accepts healthy volunteers.

Exclusion Criteria:

alcohol or illicit drugs, H2 inhibitors, opioids, or calcium-channel blockers within the last 10 days chronic pain, myocardial ischemia, psychiatric diseases.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• S(+)-Ketamine
S(+)-Ketamine 0,3mg/kg/hr intraoperative

Locations

Country	Name	City	State
Brazil	Centro Médico Campinas	Campinas	SP

Sponsors (1)

Lead Sponsor	Collaborator
Centro Medico Campinas

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

Joly V, Richebe P, Guignard B, Fletcher D, Maurette P, Sessler DI, Chauvin M. Remifentanil-induced postoperative hyperalgesia and its prevention with small-dose ketamine. Anesthesiology. 2005 Jul;103(1):147-55. — View Citation

Untergehrer G, Jordan D, Eyl S, Schneider G. Effects of propofol, sevoflurane, remifentanil, and (S)-ketamine in subanesthetic concentrations on visceral and somatosensory pain-evoked potentials. Anesthesiology. 2013 Feb;118(2):308-17. doi: 10.1097/ALN.0b013e318279fb21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine consumption		12 hours	Yes