Intravenous Methadone for Sternotomy Pain Control in Cardiac Surgery
Recruiting
Phase 3
Interventional Study
Pain, Postoperative
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 86 (estimated)
- Sponsor
- Chinese University of Hong Kong · Other
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About This Trial
Background Postoperative pain is significant in cardiac surgical patients. Perioperative analgesia with intermittent administration of opioids can result in significant fluctuations in serum opioid concentrations. Methadone should provide a rapid onset and long-term pain relief upon a single intravenous dose at induction of anaesthesia, and may reduce chronic postsurgical pain (CPSP) in cardiac su…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* adult patients age 18 or older
* elective coronary artery bypass graft (CABG), valve repair/replacement, or combined CABG/valve procedure via sternotomy
* Expected extubation within 12 hours of surgery.
Exclusion Criteria:
* emergency surgery
* aortic surgery
* redo surgery
…
Contacts