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Controlled sedation with midazolam and analgesia with nalbuphine to alleviate pain in patients undergoing subcutaneous implantable cardioverter defibrillator implantation

  • Michaël Peyrol
  • Jérémie Barraud
  • Jennifer Cautela
  • Baptiste Maille
  • Marc Laine
  • Laurent Bonello
  • Franck Thuny
  • Franck Paganelli
  • Frédéric Franceschi
  • Linda Koutbi
  • Samuel Levy
Article

Abstract

Purpose

Subcutaneous implantable cardioverter defibrillator (S-ICD) is an alternative to transvenous ICD to prevent sudden cardiac death. Subcutaneous ICD implantation frequently requires general anesthesia because of procedure nociceptive steps during creation of a large device pocket and lead tunneling. This study aims to determine if a strategy of operator-guided controlled sedation with midazolam and analgesia with nalbuphine is effective in alleviating pain during S-ICD implantation.

Methods

This prospective study included consecutive patients undergoing S-ICD implantation under controlled sedation with midazolam and combined analgesia with nalbuphine. The Critical-Care Pain Observation Tool (CPOT), a behavioral pain scale, was used for pain assessment during S-ICD placement and the Numeric Rate Scale (NRS) was used for evaluation of pain recollection after patient recovery. CPOT score of 3 or above and NRS score of 4 or above are considered to be associated with significant pain.

Results

Sixteen patients were included in this study: Ten men (62.5%) and six women with a mean age of 54 ± 11 years. Indication for S-ICD implantation was primary prevention in 11 patients (68.8%). Mean dose of administrated midazolam and nalbuphine was 0.11 ± 0.03 and 0.27 ± 0.05 mg/kg, respectively. Mean CPOT during the whole procedure was 1.4 ± 1.6. No patient presented procedural pain recollection as all 16 patients had NRS score less than 4. No serious adverse event related to sedation occurred during S-ICD implantation.

Conclusions

This study suggests that operator-guided controlled sedation with midazolam and analgesia with nalbuphine is effective to alleviate procedural pain in patients undergoing S-ICD implantation and may constitute an alternative to general anesthesia.

Keywords

Sudden cardiac death Implantable cardioverter defibrillator Subcutaneous implantable cardioverter defibrillator Ventricular arrhythmias ICD primary prevention ICD secondary prevention 

Abbreviations

S-ICD

Subcutaneous implantable cardiovertor defibrillator

T-ICD

Transvenous implantable cardiovertor defibrillator

CS

Controlled sedation

CPOT

Critical-Care Pain Observation Tool

NRS

Numerical Rating Scale

Notes

Compliance with ethical standards

Conflict of interest

Dr. Michael Peyrol received Honoraria from Boston Scientific for speaking at symposia (<5000 USD).

Funding

None.

Ethical approval

This study complies with the Declaration of Helsinki. The research protocol was approved by the Research Ethical Committee of Aix-Marseille University.

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Copyright information

© Springer Science+Business Media New York 2017

Authors and Affiliations

  • Michaël Peyrol
    • 1
    • 2
  • Jérémie Barraud
    • 1
  • Jennifer Cautela
    • 1
    • 2
  • Baptiste Maille
    • 3
  • Marc Laine
    • 1
    • 2
  • Laurent Bonello
    • 1
    • 2
  • Franck Thuny
    • 1
    • 2
  • Franck Paganelli
    • 1
  • Frédéric Franceschi
    • 3
  • Linda Koutbi
    • 3
  • Samuel Levy
    • 4
  1. 1.Assistance Publique-Hôpitaux de Marseille (APHM), Department of Cardiology, Nord HospitalAix-Marseille UniversityMarseille Cedex 20France
  2. 2.Mediterranean Association for Research and Studies in Cardiology (MARS Cardio)MarseilleFrance
  3. 3.Assistance Publique-Hôpitaux de Marseille (APHM), Department of Cardiology, Timone HospitalAix-Marseille UniversityMarseilleFrance
  4. 4.Aix-Marseille UniversityMarseilleFrance

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