Our review revealed a great heterogeneity in definition , format , and values of what is considered a clinical ly relevant difference in pain in RCTs of analgesics , and st and ardizations are advisable
OBJECTIVE To describe the  pain decrease considered as clinical ly relevant when design ing a trial and reporting its results .
Safety and efficacy of hydromorphone as an analgesic alternative to morphine in acute pain: a randomized clinical trial.
STUDY OBJECTIVE We compare a st and ard weight-based dose of intravenous hydromorphone ( Dilaudid ) to a st and ard weight-based dose of intravenous morphine in adults presenting to the ED with acute severe pain . METHODS This was a prospect i ve , r and omized , double-blind , clinical trial conducted in an academic medical center . Of the 198 adult patients presenting to the ED with acute severe pain who were r and omized to receive either intravenous hydromorphone at 0.015 mg/kg or intravenous morphine at 0.1 mg/kg , 191 patients had sufficient data for analysis . The main outcome measure was the difference between the 2 groups in pain reduction at 30 minutes as measured on a vali date d numeric rating scale . Adverse effects , pain reduction at 5 minutes and 2 hours postbaseline , and additional analgesics and antiemetics were tracked as secondary outcome measures . RESULTS The mean change of pain from baseline to 30 minutes postbaseline in patients allocated to intravenous hydromorphone was -5.5 numeric rating scale units versus -4.1 in patients allocated to intravenous morphine ( difference -1.3 ; 95 % confidence interval -2.2 to -0.5 ) . Adverse effects were similar in both groups , with the exception of pruritus , which did not occur in patients receiving hydromorphone ( 0 % versus 6 % [ difference -6 % ; 95 % confidence interval -11 % to -1 % ] ) . No patient required naloxone . CONCLUSION For the treatment of acute , severe pain in the emergency department , intravenous hydromorphone at 0.015 mg/kg represents a feasible alternative to intravenous morphine at 0.1 mg/kg
Our review revealed a great heterogeneity in definition , format , and values of what is considered a clinical ly relevant difference in pain in RCTs of analgesics , and st and ardizations are advisable
OBJECTIVE To describe the  pain decrease considered as clinical ly relevant when design ing a trial and reporting its results .