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The efficacy and side effects of Nefopam for analgesia following cardiac surgery : Randomized prospective study

The efficacy and side effects of Nefopam for analgesia following cardiac surgery : Randomized prospective study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20201014002
Enrollment
110
Registered
2020-10-14
Start date
2021-02-01
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

Patients undergoing elective open heart surgery Nefopam, cardiac surgery, opioid sparing effect,

Interventions

Patient in Nefopam group will receive Nefopam 20 mg in normal saline solution 100 ml intravenously during chest closure and continue with Nefopam 80 mg in normal saline solution 250 ml intravenously i
Experimental Drug,Placebo Comparator Drug

Sponsors

Siriraj Research Development Fund, Faculty of Medicine, Siriraj Hospital,Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: BMI less than 35 kg/m2 Undergoing elective open heart surgery e.g. CABGs, valve surgery, septal defect surgery Understand and be able to use IV-PCA independently

Exclusion criteria

Exclusion criteria: Emergency surgery Redo-surgery Impaired left ventricular systolic function (LV EF) < 40% Possess any contraindication to nero-am e.g. seizures, MAOI use, glaucoma Creatinine clearance < 40 ml/min Allergic to neropam History of chronic opioid use or any history of drug abuse

Design outcomes

Primary

MeasureTime frame
Fentanyl consumption 48 hours Total dose(mcg)

Secondary

MeasureTime frame
Time to first analgesia The first time to use IV PCA minutes,Pain score 3, 6, 12, 24, 48 hours Visual analog scale,Time to extubation Extubation Hours,ICU length of stay ICU discharge hours,Side effects: Nausea, Tachycardia, sweating, dizziness, hypoventilation 48 hours yes or no ,Cost effectiveness Discharge Total cost, patient's satisfaction with analgesia

Countries

Thailand

Contacts

Public ContactKamheang Vacharaksa

Siriraj Hospital

Vacharaksa@gmail.com0835498708

Outcome results

None listed

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