Skip to content

The effect of acetaminophen and dexmedetomidine infusion on the severity of cataract surgery pain

Comparison between the effects of Acetaminophen and Dexmedetomidine infusion and normal saline on pain severity after cataract surgery an open label randomized controlled trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190208042654N4
Enrollment
135
Registered
2021-04-12
Start date
2020-11-05
Completion date
Unknown
Last updated
2021-04-26

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

Conditions

Cataract. Diabetes mellitus due to underlying condition with diabetic cataract

Interventions

Intervention 1: Intervention group 1: infusion of Acetaminophen IV at a dose of 15 mg/kg within the first 15 minutes of surgery, slowly in total volume of 100 ml. Intervention 2: Intervention group 2:

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: ?I or II physical health score according to the classification of the American Society of Anesthesiologists Candidate for cataracts surgery Age between 50 to 80 years old Patient consent to participate in the study

Exclusion criteria

Exclusion criteria: patient contraindication of dexmedetomidine or acetaminophen ?Allergies to any of the drugs used in the trial Blood coagulation problems Altered mental status Severe cardiovascular diseases chronic obstructive pulmonary disease

Design outcomes

Primary

MeasureTime frame
Pain severity. Timepoint: immediately after surgery, 2 hours, 4 hours, and 6 hours after moving to the recovery room and then at the time of discharge. Method of measurement: Based on Visual Analog Scale (VAS) on a scale from 0 to 10.;Surgeon Satisfaction from sedation. Timepoint: After surgery. Method of measurement: Levels of satisfaction were defined as Excellent (The patient's sedation and cooperation were complete), Good (The patient cooperated despite unwanted and minor eye movements) and poor (There was a lot of unwanted eye movement during the operation and the patient did not cooperate).

Secondary

MeasureTime frame
Heart Rate. Timepoint: the start of surgery, 5, 10 and 15 minutes after starting of surgery, then at the beginning of recovery, 20, 40, 60 minutes after starting of recovery. Method of measurement: Through patient monitoring device or by taking a carotid pulse.;Respiratory rate. Timepoint: the start of surgery, 5, 10 and 15 minutes after starting of surgery, then at the beginning of recovery, 20, 40, 60 minutes after starting of recovery. Method of measurement: Counting the respiratory cycles in one minute.;Venous Oxygen Saturation. Timepoint: the start of surgery, 5, 10 and 15 minutes after starting of surgery, then at the beginning of recovery, 20, 40, 60 minutes after starting of recovery. Method of measurement: Pulse oximetry.;Systolic Blood Pressure. Timepoint: the start of surgery, 5, 10 and 15 minutes after starting of surgery, then at the beginning of recovery, 20, 40, 60 minutes after starting of recovery. Method of measurement: non-invasive blood pressure (NIBP) monitoring.;Diastolic Blood Pressure. Timepoint: the start of surgery, 5, 10 and 15 minutes after starting of surgery, then at the beginning of recovery, 20, 40, 60 minutes after starting of recovery. Method of measurement: non-invasive blood pressure (NIBP) monitoring.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDariush Moradi

Esfahan University of Medical Sciences

dmoradi@med.mui.ac.ir+98 31 3620 1992

Outcome results

None listed

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