NCT02925858

Effect of Ketamine on Analgesia Post-Cardiac Surgery

Completed Phase 4 Results posted Last updated 6 September 2019

What this trial tests

Phase 4 trial testing Normal Saline Flush, 0.9% Injectable Solution_#1 in Pain, Postoperative in 80 participants. Completed in 27 November 2018.

Timeline

28 August 2017

Primary endpoint
1 November 2018

27 November 2018

Quick facts

Lead sponsor	Jewish General Hospital
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	80
Start date	28 August 2017
Primary completion	1 November 2018
Estimated completion	27 November 2018
Sites	1 location across Canada

Drugs / interventions tested

• Normal Saline Flush, 0.9% Injectable Solution_#1 — full drug profile →
• Ketamine Hydrochloride — full drug profile →

Conditions studied

• Pain, Postoperative — all drugs for Pain, Postoperative →

Sponsor

Jewish General Hospital

Who can join

18 and older, any sex, with Pain, Postoperative. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Quantity of Opioids Used in the First 48 Hours Postoperatively Primary · First 48 hours after arrival to the ICU

Opioids used, in Dilaudid equivalents

Group	Value	95% CI
Ketamine	10.71	9.41 – 12.02
Placebo	11.14	9.68 – 12.61

Quantity of Opioids Used Secondary · 24 hours postoperatively

Quantity in mg

Group	Value	95% CI
Ketamine	6.5	5.75 – 7.24
Placebo	6.7	5.94 – 7.45

Pain Scores (Visual Analog Scale) Secondary · Postoperative days 2

Average Pain Score as reported by the patient on a numeric scale ranging from 0 (no pain) to a maximum of 10 points (worst pain imaginable)

Group	Value	95% CI
Ketamine	2	0 – 4.25
Placebo	2	0 – 5

Postoperative Nausea and Vomiting Secondary · 48 hours after ICU arrival

Whether or not the patient suffered from nausea and vomiting after surgery which required treatment

Group	Value	95% CI
Ketamine	3
Placebo	2

Intensive Care Unit Length of Stay Secondary · 1 day - 2 weeks

Number of days spent in the intensive care unit

Group	Value	95% CI
Ketamine	1	0 – 3
Placebo	2	0 – 4

Hospital Length of Stay Secondary · 5 days - 2 weeks

number of days spent in the hospital, starting from the day of surgery

Group	Value	95% CI
Ketamine	8	3 – 13
Placebo	7	2 – 12

Time to Extubation Secondary · 4 hours - 2 weeks

Number of minutes from the time of ICU arrival to extubation

Group	Value	95% CI
Ketamine	539	397 – 682
Placebo	494	383 – 605

Delirium Secondary · ICU stay

Delirium as assessed by a positive CAM-ICU score during the ICU stay

Group	Value	95% CI
Ketamine	11
Placebo	7

Time to Mobilization Secondary · During hospital stay

Time from ICU arrival until patient able to mobilize to chair, measured in hours

Group	Value	95% CI
Ketamine	32	26 – 40
Placebo	23	20 – 27

Time to Ambulation Secondary · 1 week postoperatively

Time from ICU arrival until patient able to ambulate, measured in hours

Group	Value	95% CI
Ketamine	63	54 – 76
Placebo	56	46 – 64

Sponsor's own description

Randomized, controlled, double-blind pilot study evaluating the effect of an intraoperative infusion of intravenous Ketamine on the quantity of opioid consumed postoperatively in coronary artery bypass surgery patients receiving a median sternotomy.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.