Intravenous and Topical Analgesics for Procedural Pain in Neonates

Phase 3 Completed 108 enrolled The Hospital for Sick Children Canadian Society of Hospital Pharmacists · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start: 2003-07
Primary completion: —
Completion: 2005-06

Outcome

Met primary endpoint

paper pain scores were lower in the morphine and tetracaine-morphine groups during skin preparation (mean difference, -0.22; 95% confidence interval [CI], -0.4 to -0.04; P = .02 PMID 16478902 ↗

paper CONCLUSION: In this study of ventilated neonates undergoing central line placement, morphine and tetracaine plus morphine provided superior analgesia to tetracaine PMID 16478902 ↗

Publications

Results Taddio A, Lee C, Yip A, Parvez B, McNamara PJ, Shah V. Intravenous morphine and topical tetracaine for treatment of pain in [corrected] neonates undergoing central line placement. JAMA. 2006 Feb 15;295(7):793-800. doi: 10.1001/jama.295.7.793.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Morphine	Other / unclassified	—	Intravenous
Subject	tetracaine	Other / unclassified	—	Topical

Indications

No indication recorded.