Objectives: Comparing the analgesia effect of morphine and morphine plus low dose promethazine in opium dependent trauma patients
Design: This double blind clinical trial, will be done in the emergency department of Rasoul Akram, Sina and Hafte Tir hospitals. The population of study is included in patients suffering opium addiction, who are admitted suffering severe pain(VAS≥6) due to upper or lower extremity fracture, requiring analgesia.
Setting and conduct: All the patients who are recruited according to the inclusion and exclusion criteria, will fill in the informed consent form including complete information about the research progress, and all the patients who will have satisfaction to recruit in the study, will be the principle group of study. First of all, the researcher will fill out a form including data about demographic and any history of drug hypersensitivity, duration of substance abuse and type of substance, and than evaluated the severity of pain administering the Visual Analogue Scale(VAS). Before administering any drug, using randomization method, the patient will be placed in one of two groups. Following, the Pain Score will be reevaluated using the VAS at 10, 30, 60, 90, 120 and 180 minutes after and will be documented. The researcher will calculate and document the sedation score. Vital signs such as systolic and diastolic blood pressure, pulse rate, pulse oximetry, respiratory rate before drug and during administration in regular intervals will be evaluated.
Statistical analysis in this study will be done after data gathering in SPSS software, T test will be used to compare the scores in two groups, and multivariate tests such as regression will be used to convert the effect of confounding factors in two groups.
Inclusion Criteria: Age more than 18 years old; dependency to opium; fracture in upper or lower extremity; GCS=15; VAS≥6 ; ability to talk; stable hemodynamic.
Exclusion Criteria: Psychological disorder; analgesia administration before admission in Emergency department; chronic therapy with analgesic drugs; sensitivity to morphine or promethazine; unable to understand the VAS concept; pregnancy; necessity to nerve block; unwilling to take part in the intervention; refuse to continue the intervention; major trauma which is life threatening or causing defects; any history of chronic liver; kidney; lung; cardiac disease.
Intervention: For the patients in group one, 0.1 mg/kg morphine as placebo and for the patients in the second group, 12.5 mg intravenous promethazine plus the same dose of morphine in the first group will be administered.
Main Outcome: Changes in pain severity