Effect of diphenhydramine on aggression in the elderly

Investigation of intravenous Diphenhydramine injection effects on Richmond agitation-sedation scale(RASS) in elderly patients referred to emergency ward compared to control group

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240326061366N2

Enrollment

Registered

2025-06-06

Start date

2025-07-23

Completion date

Unknown

Last updated

2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aggression in the elderly in the hospital - delirium. Acute stress reaction

Interventions

Intervention 1: Intervention group: Elderly people (60 years and older) who have visited the hospital emergency room are included in the study. Initially, the Richmond questionnaire is completed by a

Eligibility

Sex/Gender

All

Age

60 Years to No maximum

Inclusion criteria

Inclusion criteria: Willingness to participate in the study Age over 60 years RASS score greater than or equal to 1

Exclusion criteria

Exclusion criteria: Patient's unwillingness to continue participating in the study Participation in a concurrent trial Drug sensitivity The need for sedation with other medications to perform vital procedures Renal failure Receiving anti-stress and pain medications before the study

Design outcomes

Primary

Measure	Time frame
Richmond agitation sedation scale. Timepoint: at the beginning of the study and 60 minutes after drug injection. Method of measurement: The Richmond Anxiety and Sedation Scale (RASS) is a tool used to assess the level of alertness and anxiety in critically ill patients. This scale was developed by a team of physicians, nurses, and pharmacists with the aim of providing a simple scale to assess alertness and anxiety, providing sedation treatment related to the needs of patients, and also improving communication within the treatment network in the field of sedation and patient anxiety. The Richmond scale is a scale with a score range from minus 5 to plus 4. Negative levels of 1 to minus 5 indicate levels of sedation, and positive levels of 1 to plus 4 indicate increased anxiety. The lowest level of anxiety (+1) begins with stress, and the most severe is violence by the patient. A level of zero on this scale indicates that the patient is alert and calm. This scale is assessed by a physician or other member of the treatment team.	—

Measure

Time frame

Richmond agitation sedation scale. Timepoint: at the beginning of the study and 60 minutes after drug injection. Method of measurement: The Richmond Anxiety and Sedation Scale (RASS) is a tool used to assess the level of alertness and anxiety in critically ill patients. This scale was developed by a team of physicians, nurses, and pharmacists with the aim of providing a simple scale to assess alertness and anxiety, providing sedation treatment related to the needs of patients, and also improving communication within the treatment network in the field of sedation and patient anxiety. The Richmond scale is a scale with a score range from minus 5 to plus 4. Negative levels of 1 to minus 5 indicate levels of sedation, and positive levels of 1 to plus 4 indicate increased anxiety. The lowest level of anxiety (+1) begins with stress, and the most severe is violence by the patient. A level of zero on this scale indicates that the patient is alert and calm. This scale is assessed by a physician or other member of the treatment team.

—

Secondary

Measure	Time frame
The Visual Analogue Scale of pain. Timepoint: At the beginning of the study and 60 minutes after drug injection. Method of measurement: The Visual Analogue Scale of pain.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactPouya Akhoondi

Yasouj University of Medical Sciences

pouyaakhoondi@yahoo.com+98 74 3323 5153

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026