Intravenous and Topical Analgesics for Procedural Pain in Neonates

The Hospital for Sick Children108 enrolled

Overview

This study will test which type of pain medication is best for the management of pain in newborn preterm and full-term infants having a deep intravenous cannula inserted. It will compare the effectiveness of intravenous morphine alone, a local anaesthetic cream (amethocaine) alone, and both medications together. It will also determine the safety of both medications.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

108

Conditions

Pain Infant, Newborn

Interventions

morphine, amethocaineDRUG

Eligibility

Sex: ALLMin age: 1 DayMax age: 30 Days

Medical Language ↔ Plain English

Inclusion Criteria: * preterm and full-term infants in the NICU requiring a percutaneous central venous catheter * ventilatory support in the form of conventional ventilation, Continuous Positive Air Pressure (CPAP) or High Frequency Oscillation(HFO) Exclusion Criteria: * seizures * receiving muscle relaxants * skin disorders causing disruption of stratum corneum

Locations (2)

Mount Sinai Hospital

Toronto, Ontario, Canada

The Hospital for Sick Children

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

- Facial grimacing, as assessed by brow bulge, at the time of the procedure, compared among groups

Secondary Outcomes

heart rate at the time of procedure

oxygen saturation at the time of procedure

local skin reactions at the time of procedure

blood pressure for 24 hours post procedure

ventilatory support for 24 hours post procedure

Data from ClinicalTrials.gov

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