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Altered breathing with postoperative pain relief

A randomised phase 3/4 study to compare the postoperative effects of morphine versus tramadol/ketamine/parecoxib analgesia on respiratory obstructions, apnoeas and oxygen desaturation.

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12607000208404
Enrollment
70
Registered
2007-04-16
Start date
2007-06-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Many patients experience some degree of breathing difficulty after major surgery and breathing difficulties may be the basis for serious, but uncommon complications of anaesthesia and surgery. The use of sedatives and morphine-like drugs for the relief of pain, although very necessary, contributes to decreased breathing effort, pauses and obstruction. Patients with obstructive sleep apnoea (OSA) syndrome, associated with a history of snoring, observed pauses in breathing during sleep and daytime sleepiness, may be at especially high risk with anaesthesia. This syndrome is associated with obesity, and may be a partial cause for, many types of heart and lung disease. Specialized high-dependency postoperative care is advocated for these patients. We are interested in patients who do not have a definite diagnosis of OSA or severe symptoms, but who do have a high body mass index (BMI) and some abnormal airway features that imply increased risk of obstruction. Such patients may make up to 20% of patients presenting for elective surgery at the RMH. An initial respiratory monitoring study in progress, suggests that patients with these risk factors have increased breathing difficulties and reduced blood oxygen in the period after surgery. In the proposed study, patients who are considered to be at risk of breathing problems on the basis of questionnaires and examination prior to surgery, will be randomized to either standard opioid (morphine) pain relief for the first day after surgery or to a group where other pain relieving dugs (ketamine, parecoxib and tramadol) are used in an attempt to reduce opioid use while maintaining adequate pain relief. In both groups dugs will be used according to protocols approved by the Acute Pain Service at the Royal Melbourne Hospital.

Interventions

A comparison of morphine with a combination of parecoxib, ketamine and tramadol for analgesia in the first 12 hours after surgery. The tramadol to be given by patient-controlled intravenous doses. Continuous recording of respiratory data for 12-18 hours after surgery in all patients. Doses: tramadol 3mg/kg + 10mg bolus with 10min lockout, ketamine 0.3mg/kg iv + 0.1mg/kg/hr, parecoxib 40mg iv single dose.

Sponsors

Royal Melbourne Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

Obese (BMI>29) patients or airway abnormality on preoperative anaesthesia examination.Likely to require postoperative morphine or equivalent analgesia.Postoperative overnight hospital stay.

Exclusion criteria

Intrathoracic or upper-abdominal surgery. Previous adverse reaction to any study drugs including nausea or vomiting.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026