Is there any evidence to support using Dilaudid (hydromorphone) instead of morphine or fentanyl during open heart surgery?

Comment by InpharmD Researcher

Comparative evidence for use of hydromorphone over other specific analgesic agents for open heart surgery is limited to a soon-to-be published 2022 study comparing hydromorphone and morphine. Although not a randomized trial, this study pooled data from two individual randomized trials with identical inclusion and exclusion criteria. Study results demonstrated no significant differences in analgesic efficacy and safety between hydromorphone and morphine when used for postoperative pain therapy with PCA after cardiac surgery with median sternotomy. Other studies investigating analgesia after cardiac surgery fail to provide an adequate comparison to hydromorphone.

Background

A 2005 review on general anesthesia during cardiac surgery states the most commonly used opioids in cardiac surgery are fentanyl, sufentanil, and remifentanil. Morphine use has been on the decline due to histamine release and hypotension at higher doses (e.g., 1 mg/kg). [1]

References:

[1] Alwardt CM, Redford D, Larson DF. General anesthesia in cardiac surgery: a review of drugs and practices. J Extra Corpor Technol. 2005;37(2):227-235.

Literature Review

A search of the published medical literature revealed 1 study investigating the researchable question:

Is there any evidence to support using Dilaudid (hydromorphone) instead of morphine or fentanyl during open heart surgery?

Please see Table 1 for your response.


 

Patient-Controlled Analgesia After Cardiac Surgery With Median Sternotomy: No Advantages of Hydromorphone When Compared to Morphine

Design

Single-center, retrospective analysis

N= 41

Objective

To compare the efficacy, safety, and side effects of hydromorphone and morphine administered as patient-controlled analgesia (PCA) for postoperative pain therapy after cardiac surgery with median sternotomy

Study Groups

Hydromorphone (n= 21)

Morphine (n= 20)

Inclusion Criteria

Adult patients undergoing cardiac surgery with median sternotomy; aged 40 to 85 years; body mass index ≤35 kg/m2; American Society of Anesthesiologists (ASA) physical status classification 3; left ventricular ejection fraction ≥40%

Exclusion Criteria

Pregnancy; allergy to opioids; diabetes mellitus; renal, psychiatric, neurologic, chronic inflammatory, or chronic obstructive lung diseases; drug abuse; use of monoaminoxidase-inhibitors or nonsteroidal anti-inflammatory drugs; participation in another clinical trial, or pain therapy with opioids within 14 days before the start of the study

Methods

Published and unpublished data from postoperative pain therapy that were collected in 2 randomized control trials, which were performed at a single-center intensive care unit (ICU) at the University Hospital of Erlangen were pooled for retrospective analysis. In the first study, a total of 25 out of 50 patients were assigned to receive pain therapy by PCA with hydromorphone whereas 25 out of 50 patients were assigned to receive pain therapy by PCA with morphine in the second study.

Duration

First study: December 2013 to April 2015

Second study: April 2015 to December 2016

Outcome Measures

Numerical pain rating scale (NRS) at rest and under deep inspiration, hemodynamics and respiration stability, incidence of adverse effects

Baseline Characteristics

 

Hydromorphone (n= 21)

Morphine (n= 20)

 

Age, years

61 68  

Male/Female

17/4 17/3  

Body mass index, kg/m2

27.5 27.1  

Type of surgery

Coronary artery bypass graft

Aortic valve replacement

 

20

1

 

18

2

 

Duration of anesthesia, min*

Duration of surgery, min

Aortic clamping time, min*

277

216

38

309

201

46

 

Number of bypass grafts

Number of chest tubes

2

2

2

2

 

Medication dose

Propofol, mg/kg/h

Sufentanil, mcg/kg/h

 

4.4

0.51

 

4.5

0.47

 

*Significant difference between the two groups (p< 0.05)

Results

Endpoint

Hydromorphone (n= 21)

Morphine (n= 20)

p-value

Median (range) NRS rating

At rest

Under deep inspiration

 

1.5 (0 to 5)

3 (0 to 6)

 

0.5 (0 to 5)

4 (0 to 7)

 

0.41

0.07

Time to extubation (interquartile range [IQR], h

3.2 (2.7 to 4.2)

3.6 (2.9 to 4.4) 0.42

Duration of PCA (IQR), h

14.1 (13.0 to 15.5)

13.5 (11.7 to 15.0)

0.31

Opioid dose (IQR), mcg/kg/h

Dose until extubation

Dose during PCA

Total dose

 

3.52 (3.22 to 3.95)

3.01 (2.09 to 4.31)

3.15 (2.32 to 4.07)

 

25.6 (18.6 to 29.1)

17.2 (11.9 to 24.3)

19.1 (15.2 to 24.7)

 

-

-

Positive requests/h

Negative requests/h

1.54 (0.98 to 2.06)

1.54 (0.28 to 2.26)

0.88 (0.61 to 1.31)

0.42 (0.07 to 1.89)

0.054

0.36

Adverse Events

Common Adverse Events were not significantly different between hydromorphone vs. morphine: nausea, 5 (24%) vs. 7 (35%); vomiting, 1 (5%) vs. 1 (5%); shivering, 1 (5%) vs. 4 (20%)

Serious Adverse Events: respiratory depression, 2 (10%) vs. 2 (10%)

Percentage that Discontinued due to Adverse Events: N/A

Study Author Conclusions

There were no significant differences in analgesic efficacy and safety between hydromorphone and morphine when used for post-operative pain therapy with PCA after cardiac surgery with median sternotomy.

InpharmD Researcher Critique

In addition to the limitations inherent to the retrospective design, this study excluded patients with severe comorbidities, potentially reducing the external validity of the results. 



References:

Wehrfritz A, Senger AS, Just P, et al. Patient-Controlled Analgesia After Cardiac Surgery With Median Sternotomy: No Advantages of Hydromorphone When Compared to Morphine. J Cardiothorac Vasc Anesth. 2022;36(9):3587-3595. doi:10.1053/j.jvca.2022.04.051