None listed
Conditions
Interventions
Post-operative analgesia via PCA containing either tramadol 600mg in 30mls n.saline or morphine 60mg in 30mls n. saline. PCA commenced in recovery and programmed to deliver an initial loading dose of 0.1ml study drug/kg body weight. Patient demand boluses then set at 0.5ml study drug with 5minute lockout and no dose limit. Bolus dose can be inreased to 1ml if analgesia inadequate. If increase in dose remains inadequate then patient will be withdrawn from trial and receive alternative analgesia
Post-operative analgesia via PCA containing either tramadol 600mg in 30mls n.saline or morphine 60mg in 30mls n. saline. PCA commenced in recovery and programmed to deliver an initial loading dose of 0.1ml study drug/kg body weight. Patient demand boluses then set at 0.5ml study drug with 5minute lockout and no dose limit. Bolus dose can be inreased to 1ml if analgesia inadequate. If increase in dose remains inadequate then patient will be withdrawn from trial and receive alternative analgesia as per Acute Pain Service protocol. Study duration < 1 week for each subject. Computer programme randomisation by pharmacy.
Sponsors
Stephan Schug
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
ASA 1-3, elective colorectal surgery.
Exclusion criteria
Patients with known gastrointestinal tract disorders, previous abdominal radiotherapy, clinically relevant liver or renal impairment, chronic pre-op opiod use, patients unsuitable for PCA, planned epidural analgesia.
Outcome results
None listed