Intravenous and Topical Analgesics for Procedural Pain in Neonates

The Hospital for Sick Children

Status and phase: Completed; Phase 3

Conditions: Infant, Newborn; Pain

Treatments: Drug: morphine, amethocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT00213200

0019990251

Details and patient eligibility

About

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.

Sex: All

Ages: 1 to 30 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind