Comparison the effect of intravenous analgesia by paracetamol versus fentanyl in patients undergo coronary heart surgery

Clinical trial of the effect of intravenous analgesia by paracetamol compared to fentanyl in patients undergo coronary heart bypass surgery

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016121131351N1

Enrollment

160

Registered

2017-01-27

Start date

2015-10-02

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Coronary artery bypass. Atherosclerotic heart disease

Interventions

Intervention 1: First group: Bolus intravenous infusion of 50 microgram fentanyl followed by pump infusion of 10 microgram per cc in speed of 4 cc in hour. Intervention 2: Second group: Bolus intraven

Treatment - Drugs

First group: Bolus intravenous infusion of 50 microgram fentanyl followed by pump infusion of 10 microgram per cc in speed of 4 cc in hour

Second group: Bolus intravenous infusion of 15 microgram per kilogram of paracetamol followed by pump infusion of 25 microgram per cc in speed of 4 cc in hour

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Main inclusion criteria: pre-operation ejection fraction above 30%; class one to three of ASA; no simultaneous heart valves involvement; no need of intra-aort pump usage during the operation. Main exclusion criteria: positive history of sensitivity to study drugs; uncontrolled systemic disease such as diabetes; addiction to alcohol and drugs; positive history of psychologic disease and depression; asthma and other hypersensitivity reactions; fracture of sternum and ribs intraoperation; pre-operative liver enzymes rising higher than two folds; other chest pain causes other than coronary arteries; presence of neurologic signs and symptoms; any type of consciousness impairment pre-operation.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Postoperation pain. Timepoint: Two houres, four houres, eight houres, 12 houres and 24 houres after surgery. Method of measurement: VAS Criteria.;Mean arterial pressure. Timepoint: Up to 24 hours after surgery in intervals of every 4 hours. Method of measurement: Millimeter of mercury.;Heart rate. Timepoint: Up to 24 hours after surgery in intervals of every 4 hours. Method of measurement: Beats in minute.	—

Measure

Time frame

Postoperation pain. Timepoint: Two houres, four houres, eight houres, 12 houres and 24 houres after surgery. Method of measurement: VAS Criteria.;Mean arterial pressure. Timepoint: Up to 24 hours after surgery in intervals of every 4 hours. Method of measurement: Millimeter of mercury.;Heart rate. Timepoint: Up to 24 hours after surgery in intervals of every 4 hours. Method of measurement: Beats in minute.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactYalda Moeini

Zahedan University of Medical Sciences

yaldamoeini@zaums.ac.ir+98 54 3322 4991

Outcome results

None listed

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