Effects of fentanyl(opoid analgesic) and dexmedetomidine (sedative -analgesic)on pain and discomfort associated with central venous catheter insertion

Recruiting

Conditions: patients requiring central venous access with planned placement in the internal jugular vein as a part of normal care

Registration Number: CTRI/2014/02/004397

Lead Sponsor: Sri Venkateswara Institute of Medical Sciences

Brief Summary: The purpose of this randomised prospective double-blind clinical trial is to evaluate objectively whether a single dose of fentanyl (1Âµg.kg-1)or dexmedetomidine (1Âµg.kg-1) with placebo control(0.9% NS) before the procedure is more efficient for prevention pain and discomfort during central venous catheterisation.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 60

Inclusion Criteria

patients requiring central venous access with planned placement in the internal jugular vein (IJV) as a part of normal care were consented and enrolled in the study.
No systemic analgesics had been administered for at least 4 hours before the procedure.
Patients were included in the study if they were awake, alert, and oriented and their medical condition was stable enough to allow them to understand and use visual analogue scale(VAS)and were 18 to 65year old.

Exclusion Criteria

Patients were excluded from the study if they were receiving neuromuscular blocking medications or had a disease or injury that impaired sensory transmission proximal to the procedure site.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Discomfort was assessed using an 11-point verbal numeric rating discomfort scale (VNRDS) from 0 to 10 (0: none, 10: extreme discomfort); pain was assessed by a verbal numeric rating pain scale (VNRPS) from 0 to 10 (0: no pain, 10: the worst pain imaginable) .	five time points: time 1, at base line (T1); time 2, after initial local anesthetic injection (LAI)(T2); time 3,immediately after the procedure, the patient was asked to report the peak pain experienced during the procedure (T3);time 4, 10 minutes after completion of the procedure (T10) and time 5,60 minutes after completion of the procedure (T60)

Secondary Outcome Measures

Name	Time	Method
Sedation was assessed on a 6-point modified Observerâ€™s assessment of alertness/sedation(OAA/S) scale .	Respiratory depression,Pruritus,Nausea and vomitting

Trial Locations

Locations (1): Intensive care units and Recovery room of Sri Venkateswara Institute of Medical Sciences
🇮🇳
Chittoor, ANDHRA PRADESH, India
Intensive care units and Recovery room of Sri Venkateswara Institute of Medical Sciences
🇮🇳Chittoor, ANDHRA PRADESH, India
Aloka Samantaray
Principal investigator
9493547653
aloksvims@gmail.com