Tapentadol versus oxycodone analgesia and side effects after laparoscopic hysterectomy: A randomised controlled trial.
Journal
European journal of anaesthesiology
ISSN: 1365-2346
Titre abrégé: Eur J Anaesthesiol
Pays: England
ID NLM: 8411711
Informations de publication
Date de publication:
01 09 2021
01 09 2021
Historique:
pubmed:
12
1
2021
medline:
21
8
2021
entrez:
11
1
2021
Statut:
ppublish
Résumé
Tapentadol is an opioid, which acts as a μ-opioid receptor agonist and inhibits noradrenaline reuptake in the central nervous system. This dual mechanism of action results in synergistic analgesic effects and potentially less side effects. This has been shown in treatment of chronic pain but postoperative studies are sparse. The main aim was to compare the analgesic effect of tapentadol with oxycodone after laparoscopic hysterectomy. Opioid side effects were recorded as secondary outcomes. Randomised, blinded trial. Single-centre, Oslo University Hospital, Norway, December 2017 to February 2019. Eighty-six opioid-naïve American Society of Anesthesiologists physical status 1 to 3 women undergoing laparoscopic hysterectomy for nonmalignant conditions. The patients received either oral tapentadol (group T) or oxycodone (group O) as part of multimodal pain treatment. Extended-release study medicine was administered 1 h preoperatively and after 12 h. Immediate-release study medicine was used as rescue analgesia. Pain scores, opioid consumption and opioid-induced side effects were evaluated during the first 24 h after surgery. The groups scored similarly for pain at rest using a numerical rating scale (NRS) 1 h postoperatively (group T 4.4, 95% CI, 3.8 to 5.0, group O 4.6, 95% CI, 3.8 to 5.3). No statistically significant differences were found between the groups for NRS at rest or while coughing during the 24-h follow-up period (P = 0.857 and P = 0.973). Mean dose of oral rescue medicine was similar for the groups (P = 0.914). Group T had significantly lower odds for nausea at 2 and 3 h postoperatively (P = 0.040, P = 0.020) and less need for antiemetics than group O. No differences were found for respiratory depression, vomiting, dizziness, pruritus, headache or sedation. We found tapentadol to be similar in analgesic efficacy to oxycodone during the first 24 h after hysterectomy, but with significantly less nausea. ClinicalTrials.gov, NCT03314792.
Sections du résumé
BACKGROUND
Tapentadol is an opioid, which acts as a μ-opioid receptor agonist and inhibits noradrenaline reuptake in the central nervous system. This dual mechanism of action results in synergistic analgesic effects and potentially less side effects. This has been shown in treatment of chronic pain but postoperative studies are sparse.
OBJECTIVES
The main aim was to compare the analgesic effect of tapentadol with oxycodone after laparoscopic hysterectomy. Opioid side effects were recorded as secondary outcomes.
DESIGN
Randomised, blinded trial.
SETTING
Single-centre, Oslo University Hospital, Norway, December 2017 to February 2019.
PATIENTS
Eighty-six opioid-naïve American Society of Anesthesiologists physical status 1 to 3 women undergoing laparoscopic hysterectomy for nonmalignant conditions.
INTERVENTION
The patients received either oral tapentadol (group T) or oxycodone (group O) as part of multimodal pain treatment. Extended-release study medicine was administered 1 h preoperatively and after 12 h. Immediate-release study medicine was used as rescue analgesia.
MAIN OUTCOME MEASURES
Pain scores, opioid consumption and opioid-induced side effects were evaluated during the first 24 h after surgery.
RESULTS
The groups scored similarly for pain at rest using a numerical rating scale (NRS) 1 h postoperatively (group T 4.4, 95% CI, 3.8 to 5.0, group O 4.6, 95% CI, 3.8 to 5.3). No statistically significant differences were found between the groups for NRS at rest or while coughing during the 24-h follow-up period (P = 0.857 and P = 0.973). Mean dose of oral rescue medicine was similar for the groups (P = 0.914). Group T had significantly lower odds for nausea at 2 and 3 h postoperatively (P = 0.040, P = 0.020) and less need for antiemetics than group O. No differences were found for respiratory depression, vomiting, dizziness, pruritus, headache or sedation.
CONCLUSION
We found tapentadol to be similar in analgesic efficacy to oxycodone during the first 24 h after hysterectomy, but with significantly less nausea.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT03314792.
Identifiants
pubmed: 33428347
doi: 10.1097/EJA.0000000000001425
pii: 00003643-202109000-00011
doi:
Substances chimiques
Analgesics, Opioid
0
Phenols
0
Oxycodone
CD35PMG570
Tapentadol
H8A007M585
Banques de données
ClinicalTrials.gov
['NCT03314792']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
995-1002Informations de copyright
Copyright © 2021 European Society of Anaesthesiology and Intensive Care. Unauthorized reproduction of this article is prohibited.
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