Comparing the Efficacy of Methadone and Tincture of Opium in Controlling Agitation Caused by Withdrawal Syndrome in Opium-Addicted Patients in the Intensive Care Unit: A Randomized Trial Study

Document Type : Original Article


1 Robarts Research Institute, University of Western Ontario, Canada AND Pharmaceutical Sciences Research Center AND School of Pharmacy, Shahid Sadoughi University of Medical Sciences, Yazd, Iran

2 Pharmaceutics Research Center AND School of Pharmacy, Kerman University of Medical Sciences, Kerman, Iran

3 School of Medicine, Kerman University of Medical Sciences, Kerman, Iran


Background: Few studies have been conducted regarding the comparison of the efficacy of methadone and
tincture of opium (TOP) in controlling agitation induced by withdrawal syndrome. Therefore, the current
randomized trial study is carried out with the aim to evaluate comparisons on the efficacy of methadone and
TOP in controlling agitation caused by withdrawal syndrome in opium addicted patients in the intensive care
units (ICUs).
Methods: This clinical trial study was conducted on 60 patients admitted to ICU of Shahid Bahonar Hospital,
Kerman, Iran. After classification of the patients into two groups, the first and second groups consumed
methadone syrup (5 mg/ml) and TOP (10 mg/ml), respectively. Agitation in these patients was assessed
through the Richmond Agitation-Sedation Scale (RASS). Vital signs were also assessed. Paired sample t-test
and independent t-test were used for data analysis.
Findings: In the current study, the administered dose of methadone and TOP was 36.17 ± 26.99 and
112.67 ± 102.74 mg, respectively (P < 0.010). Methadone administration led to a significant decrease of the
patients’ vital signs, including systolic blood pressure, heart rate, respiratory rate, and Glasgow Coma Scale
(GCS) (P < 0.05). Though TOP administration decreased systolic blood pressure and GCS significantly
(P < 0.05), it had no effect on patients’ diastolic blood pressure, body temperature, heart rate, and
respiratory rate (P > 0.05). In total, no significant difference was detected between two groups regarding
vital signs (P > 0.05). However, a significant difference was seen between methadone and TOP groups in
terms of RASS score (P < 0.01).

Conclusion: According to the results of the current study, lower dose of methadone, compared to TOP, could
control agitation caused by opium withdrawal symptoms.