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Comparison of effects of pain treatment after cardiac surgery between combined paracetamol and nefopam with fentanyl and fentanyl only : A randomized controlled trial

Comparison of effects of pain treatment after cardiac surgery between combined paracetamol and nefopam with fentanyl and fentanyl only : A randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20201113001
Enrollment
120
Registered
2020-11-13
Start date
2021-01-25
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Patient undergoing elective cardiac surgery Nefopam, cardiac surgery

Interventions

Paracetamol 10mg/kg add nefopam 20 mg in normal saline up to 100 ml iv drip in 1 hour q 6 hours for 24 hours,Normal saline 100 ml iv drip in 1 hour q 6 hours for 24 hours
Experimental Drug,Placebo Comparator Drug
Multimodal ,Conventional

Sponsors

King chulalongkorn memorial hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Patients undergoing elective cardiac surgery e.g. CABG or Single valve repair 2.ASA II-III Cardiac risk index more than 3

Exclusion criteria

Exclusion criteria: 1.History of drug allergy which is used in this study e.g. paracetamol nefopam 2.unable to use IV PCA device 3.Echo: EF < 40% CHF cardiomegaly 4.current use of MAO inhibitors drug 5.liver cirrhosis or ESRD 6.epilepsy of history of seizures 7.history of acute angle glaucoma 8.High risk for urinary retention e.g. BPH

Design outcomes

Primary

MeasureTime frame
Pain score(rest, movement) 24 hrs, 48 hrs, 72 hrs, 96 hrs VAS,Triflow performance 48hrs, 72 hrs, 96hrs Scale of triflow performance ,Fentanyl consumption 24 hrs, 48 hrs Total dose (mcg)

Secondary

MeasureTime frame
Postoperative nausea and vomiting 48 hrs, 72 hrs, 96 hrs Record number of Postoperative nausea and vomiting ,Postoperative derilium 24 hrs, 48hrs, 72hrs, 96hrs Record Confusion Assessment Method for the ICU(CAM ICU),Sedation score 24hrs, 48hrs Record The university of Michigan sedation scale (UMSS),Heart rate, blood pressure During infuse medications 1 hrs Record vital signs q 5 min

Countries

Thailand

Contacts

Public ContactAPAPIT LAOPORN

Faculty of medicine, Chulalongkorn university

apapit.l20@chula.md0936298998

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026