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Comparison of haloperidol and midazolam in restless management of patients referred to the Emergency Department: A double-blinded, randomized clinical trial.

Esmailian M, Ahmadi O, Taheri M, Zamani M - J Res Med Sci (2015)

Bottom Line: The time to achieve sedation, need for rescue dose, need to resedation within the first 60 min, and adverse effects of drugs were compared among the groups.The results of the present study show that administration of midazolam and haloperidol have similar efficacy in the treatment of restless symptoms with the same recovery time from drug effects for referring patients to the ED.In addition, none of the adverse effects were observed in this study.

View Article: PubMed Central - PubMed

Affiliation: Department of Emergency Medicine, Al-Zahra Hospital, Isfahan University of Medical Sciences, Isfahan, Iran.

ABSTRACT

Background: Restless and violent behaviors are common in Emergency Departments (EDs), which need therapeutic interventions in most of the times. The first-generation anti-psychotic drugs are one of the most applicable therapeutic agents in the management of such patients, but their use has some limitations. Some studies suggest midazolam as an alternative medicine. Therefore, this study was performed with the aim of comparison of the efficacy and safety of haloperidol and midazolam in the restless management of referring patients to EDs.

Materials and methods: The present double-blinded trial was done on patients needed sedation and referred to the ED of Alzahra Hospital, Isfahan, Iran, in 2014. The patients were categorized into two random groups of haloperidol (5 mg) and midazolam receivers (2.5 mg for those weighing <50 kg and 5 mg in >50 kg), as intramuscular administration. The time to achieve sedation, need for rescue dose, need to resedation within the first 60 min, and adverse effects of drugs were compared among the groups.

Results: Forty-eight patients were entered to the study. The mean age in the haloperidol and midazolam groups was 44.8 ± 4.1 years and 45.5 ± 4.7 years, respectively (P = 0.91). The mean time of sedation in the haloperidol and midazolam groups was 5.6 ± 0.3 min and 5.2 ± 0.1 min, respectively (P = 0.31). The mean time of full consciousness after sedation was 36.2 ± 4.5 min and 38.2 ± 3.4 min in the haloperidol and midazolam groups, respectively (P = 0.72). On average, time to arousal in the midazolam group was 10.33 min more than the haloperidol group, but it was not statistically significant.

Conclusion: The results of the present study show that administration of midazolam and haloperidol have similar efficacy in the treatment of restless symptoms with the same recovery time from drug effects for referring patients to the ED. In addition, none of the adverse effects were observed in this study.

No MeSH data available.


Related in: MedlinePlus

Consort diagram of participant flow
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Figure 5: Consort diagram of participant flow

Mentions: The patients were categorized into two random groups of haloperidol (5 mg, single-dose, intramuscular (IM) administration) and midazolam receivers (2.5 mg for those weighing <50 kg and 5 mg in >50 kg, single-dose, IM administration) [Figure 5]. Induction of sedation was evaluated by a valid criterion with three scores Table 1 that from three (turbulence intensity, need to full harness, and require constant care) to one (without restless, without need to permanent supervision, and dormant), the appropriate sedation was considered as the score of three.[11] Co-researchers were trained for using this criterion and finding appropriate condition to use rescue dose that was detected only by a trained physician. The maximum permissible dose for midazolam was 20 mg and if the patient needed more, the physician was informed from the prescribed drug and initiated other treatments. In such cases, the patient was excluded from the study and this considered as a treatment failure. All the patients were consistently monitored and their vital signs (body temperature, blood pressure, respiratory rate, and pulse rate), arterial oxygen saturation level, blood sugar level, and side effects were recorded.


Comparison of haloperidol and midazolam in restless management of patients referred to the Emergency Department: A double-blinded, randomized clinical trial.

Esmailian M, Ahmadi O, Taheri M, Zamani M - J Res Med Sci (2015)

Consort diagram of participant flow
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4696368&req=5

Figure 5: Consort diagram of participant flow
Mentions: The patients were categorized into two random groups of haloperidol (5 mg, single-dose, intramuscular (IM) administration) and midazolam receivers (2.5 mg for those weighing <50 kg and 5 mg in >50 kg, single-dose, IM administration) [Figure 5]. Induction of sedation was evaluated by a valid criterion with three scores Table 1 that from three (turbulence intensity, need to full harness, and require constant care) to one (without restless, without need to permanent supervision, and dormant), the appropriate sedation was considered as the score of three.[11] Co-researchers were trained for using this criterion and finding appropriate condition to use rescue dose that was detected only by a trained physician. The maximum permissible dose for midazolam was 20 mg and if the patient needed more, the physician was informed from the prescribed drug and initiated other treatments. In such cases, the patient was excluded from the study and this considered as a treatment failure. All the patients were consistently monitored and their vital signs (body temperature, blood pressure, respiratory rate, and pulse rate), arterial oxygen saturation level, blood sugar level, and side effects were recorded.

Bottom Line: The time to achieve sedation, need for rescue dose, need to resedation within the first 60 min, and adverse effects of drugs were compared among the groups.The results of the present study show that administration of midazolam and haloperidol have similar efficacy in the treatment of restless symptoms with the same recovery time from drug effects for referring patients to the ED.In addition, none of the adverse effects were observed in this study.

View Article: PubMed Central - PubMed

Affiliation: Department of Emergency Medicine, Al-Zahra Hospital, Isfahan University of Medical Sciences, Isfahan, Iran.

ABSTRACT

Background: Restless and violent behaviors are common in Emergency Departments (EDs), which need therapeutic interventions in most of the times. The first-generation anti-psychotic drugs are one of the most applicable therapeutic agents in the management of such patients, but their use has some limitations. Some studies suggest midazolam as an alternative medicine. Therefore, this study was performed with the aim of comparison of the efficacy and safety of haloperidol and midazolam in the restless management of referring patients to EDs.

Materials and methods: The present double-blinded trial was done on patients needed sedation and referred to the ED of Alzahra Hospital, Isfahan, Iran, in 2014. The patients were categorized into two random groups of haloperidol (5 mg) and midazolam receivers (2.5 mg for those weighing <50 kg and 5 mg in >50 kg), as intramuscular administration. The time to achieve sedation, need for rescue dose, need to resedation within the first 60 min, and adverse effects of drugs were compared among the groups.

Results: Forty-eight patients were entered to the study. The mean age in the haloperidol and midazolam groups was 44.8 ± 4.1 years and 45.5 ± 4.7 years, respectively (P = 0.91). The mean time of sedation in the haloperidol and midazolam groups was 5.6 ± 0.3 min and 5.2 ± 0.1 min, respectively (P = 0.31). The mean time of full consciousness after sedation was 36.2 ± 4.5 min and 38.2 ± 3.4 min in the haloperidol and midazolam groups, respectively (P = 0.72). On average, time to arousal in the midazolam group was 10.33 min more than the haloperidol group, but it was not statistically significant.

Conclusion: The results of the present study show that administration of midazolam and haloperidol have similar efficacy in the treatment of restless symptoms with the same recovery time from drug effects for referring patients to the ED. In addition, none of the adverse effects were observed in this study.

No MeSH data available.


Related in: MedlinePlus