Opioid sparing effect and safety of nefopam in patient controlled analgesia after laparotomy: A randomized, double blind study

Hyun Seung Jin, Yong Chul Kim, Yongjae Yoo, Changsoon Lee, Chan Woo Cho, Won-Joong Kim, Hyun Seung Jin, Yong Chul Kim, Yongjae Yoo, Changsoon Lee, Chan Woo Cho, Won-Joong Kim

Abstract

Objectives: A double-blind randomised study to evaluate the opioid sparing effect and safety of nefopam when administered via intravenous patient controlled analgesia (PCA) with fentanyl.

Methods: Patients planned for elective open laparotomy, were randomly assigned to receive into fentanyl 25 µg/ml (SF group) or nefopam 2.4 mg/ml plus fentanyl 25 µg/ml (NF group). Patients were assessed before surgery and for 24 h postoperatively.

Results: Total PCA fentanyl consumption was significantly lower in the NF group (n = 35) than the SF group (n = 36). Pain scores were significantly lower and patients' satisfaction with treatment significantly better in the NF group than the SF group. Dry mouth and dizziness were significantly more frequent in the NF group than the SF group. There were no other statistically significant between-group differences in the incidence of adverse events.

Conclusions: Intravenous PCA using nefopam + fentanyl following laparotomy has an opioid sparing effect and is associated with a low incidence of some of the typical opioid related adverse events.

Trial registry: Clinicaltrials.gov Registration No: NCT02596269.

Keywords: Adverse events; fentanyl; opioid sparing; laparotomy; nefopam; patient controlled analgesia.

© The Author(s) 2016.

Figures

Figure 1.
Figure 1.
Flow diagram showing progress through the phases of the randomised double blind study comparing the efficacy and safety of intravenous nefopam/fentanyl versus fentanyl alone as postoperative patient controlled analgesia following laparotomy.
Figure 2.
Figure 2.
Postoperative pain score (11-point numerical rating scale [NRS]) on movement in patients receiving patient controlled analgesia (PCA) with nefopam + fentanyl (NF group) or fentanyl alone (SF group) following laparotomy. *P < 0.0001; Mann–Whitney U-test.
Figure 3.
Figure 3.
Postoperative pain score (11-point numerical rating scale [NRS]) at rest in patients receiving patient controlled analgesia (PCA) with nefopam + fentanyl (NF group) or fentanyl alone (SF group) following laparotomy. *P < 0.0001; Mann–Whitney U-test.
Figure 4.
Figure 4.
Treatment satisfaction at 24 h postsurgery in patients receiving patient controlled analgesia (PCA) with nefopam + fentanyl (NF group) or fentanyl alone (SF group) following laparotomy. There is a significant between-group difference in proportions (P < 0.0001; χ2-test).
Figure 5.
Figure 5.
Postoperative heart rate in patients receiving patient controlled analgesia (PCA) with nefopam + fentanyl (NF group) or fentanyl alone (SF group) following laparotomy. *P < 0.01,**P < 0.05; Student’s t-test.

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Source: PubMed

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