Adjuvant nefopam versus standard of care in mechanically ventilated surgical critically ill patients: A randomized, double-blind controlled study

Background

Multimodal analgesia, through combining different classes of analgesia that target pain pathways with different mechanisms reduces opioid consumption. This study aimed to determine the impact of adjunct nefopam infusion on opiate consumption when added to standard-of-care analgesia and sedation in mechanically ventilated critically ill patients.

Methods

This was a prospective, randomized, active control, double-blind study. Patients admitted to the ICU, being mechanically ventilated and candidates for analgesia and sedation protocols were randomized to the intervention group (n = 30) or to the control group (n = 30).

The primary outcome was the cumulative dose of fentanyl in the first 24 h after inclusion. The secondary outcomes were the proportion of patients with positive pain scores, change in mean arterial pressure (MAP), heart rate (HR), ICU mortality, and others.

Results

A total of 60 patients were included in the final analysis; median (Q1, Q3) cumulative fentanyl consumption mcg/24 h was significantly (p = 0.001) lower in the intervention group compared to the control group 1300 (575, 2087.5) vs. 2400 (1612.5, 2665) mcg/24 h respectively. Pain and sedation scores were comparable between the two study groups. ICU mortality was 25 (83.3%) in the intervention group vs. 20 (66.7%) in the control group (P = 0.136).

Conclusions

Nefopam was found to be an effective non-opioid option for analgesia in mechanically ventilated surgical and trauma critically ill patients, and more studies are needed to evaluate its safety.

Clinical trial registry and number

ClinicalTrials.gov (identifier: NCT05071352).