Study to determine whether Remifentanil is effective for treating procedural pain in neonates

Phase 2

Recruiting

• Conditions: Pain relief for neonates undergoing insertion of a central venous catheter; Reproductive Health and Childbirth - Complications of newborn; Anaesthesiology - Pain management

• Registration Number: ACTRN12612000385842
• Lead Sponsor: Dr Susan M Lord

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-04-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Medically stable neonates
Inpatient in JHCH NICU Level 3 Nursery
Require insertion of a central venous catheter for their medical care
24–44 weeks corrected gestational age at the time of procedure

Exclusion Criteria

Prior participation in this study (an infant can only participate once)
Major congenital anomalies
Severe hypoxic ischaemic encephalopathy
Current clinical seizures
Concomitant muscle relaxant
Emergency central line insertions
Lack of peripheral venous access for administration of study drug

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is to determine the efficacy of remifentanil infusion for alleviating pain in neonates requiring insertion of central venous lines for their medical care, using pain scores (PIPPS) and facial grimacing derived from clinical monitoring data and facial coding data[Baseline (T0), during skin preparation (T1), during needle insertion (T2), and during recovery (T3).]

Secondary Outcome Measures

Name	Time	Method
To collect steady-state pharmacokinetic data for analgesic infusions of remifentanil in neonates of varying gestational maturity.[Once during procedure.]