Tramadol vs. Morphine for refractory pain in the recovery room

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Objective The objective of this study is to determine whether patients who have ongoing post-operative pain despite administration of morphine in the recovery room respond better to tramadol than to further morphine. Hypothesis Our hypothesis is that there will be no difference in the time to readiness to discharge from recovery in those patients who receive either morphine or tramadol for ongoing post-operative pain in the recovery room. Methods All healthy patients who are coming for major surgery would be eligible to participate in the study. Recruitment of the patients and the informed consent process would take place pre-operatively. Conduct of the anaesthetic would be entirely at the discretion of the attending anaesthetist. Once in the patients were in the recovery room they would receive standard recovery room cares. This care includes monitoring of pain scores and titration of morphine 1-2mg IV each 5 minutes (up to 10mg) to achieve patient comfort. If any patient had a pain score greater than 5 at rest 5 minutes after the last dose of morphine then they would be randomised to receive either further morphine (titrated dose up to 10mg more) or tramadol (titrated dose up to 100mg) until pain was controlled. If after this period of further drug titration a patient’s pain score remained greater than 5 then the attending anaesthetist would take over management of that patient’s pain. The recovery room nurses would be blinded to the group allocation of the patients. The medications will be provided in identical pre-mixed syringes labelled to identify the study but not the drug contained. Each study syringe would contain 10 ml of fluid, either morphine 10mg/10ml or tramadol 100mg/10ml. Previous work has suggested that the conversion ratio between the 2 medications is between 8.5:1 and 11:1 . Data will be collected from the recovery room observations, which include pain scores, vital sign observations and administration of anti-emetics and observations whether or not the patient is feeling nauseous or is vomiting. Time to readiness for discharge will be measured from the time the patient receives the first dose of the study medication to the time that they meet the recovery room criteria for discharge. The proportion of patients failing to meet discharge criteria in each arm of the study will be compared and the reasons why they did not meet the criteria analysed. The proportion of patients who did not receive study drugs will be recorded and their time in recovery will provide a comparator to those whose pain was difficult to control. Inclusion criteria - Major surgery - ASA 1 or 2 or 3 - Morphine based analgesia indicated post-operatively - Adequate English language skills - Adequate intellectual capacity - Age between 18-80 years old Exclusion criteria - Patient refusal - Allergy to either morphine or tramadol - Chronic opioid use - Severe chronic pain - Epilepsy - Pregnancy - Depression requiring treatment with monoamine oxidase inhibitor or SSRI - Severe renal or hepatic impairment - Expected to be intubated and ventilated electively post-operatively Analysis Time to readiness to discharge and mean pain scores will be compared with a 2-tailed student t-test. Presence of side effects will be compared with Chi squared testing. Other data will be presented as mean and standard deviation where appropriate. A power analysis using an alpha value of 0.05 and a beta value of 0.8 yielded a sample size of 43 patients for each group. Accounting for potential drop outs and incomplete data collection we aim to enrol 50 patients in each group for a total of 100 patients.

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