Minimizing needle poke pain in newborn infants with a pain relieving cream and sugar water

Evaluation of liposomal lidocaine and oral sucrose for treatment of pain in newborn infants undergoing venipuncture: a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN82181559

Enrollment

330

Registered

2007-08-23

Start date

2007-08-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newborns undergoing painful procedure Signs and Symptoms Infant pain

Interventions

Experimental arm one: 1 g of liposomal lidocaine to the dorsum of hand for 30 - 40 minutes prior to venipuncture and 2 ml of placebo water by mouth using a syringe over 1 - 2 minutes prior to venipunc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All healthy full-term (greater than 37 weeks gestational age) newborn infants (either sex)

Exclusion criteria

Exclusion criteria: 1. Neonatal Intensive Care Unit (NICU) admission 2. Asphyxia, seizures 3. Major birth defects (heart, brain, genetic syndrome) 4. Circumcised during study 5. Receiving analgesia/sedatives

Design outcomes

Primary

Measure	Time frame
Infant pain during venipuncture as assessed by facial grimacing response - the score will incorporate three facial actions: brow bulge, eye squeezed shut, naso-labial furrow, during venipuncture.	—

Secondary

Measure	Time frame
1. Visual Analog Scale (VAS), during venipuncture 2. Cry duration, during venipuncture 3. Heart rate, during venipuncture 4. Number of attempts until procedure completion, from first needle poke to completion 5. Endomorphins -1, -2, levels, before and 10 minutes after sucrose/sucrose placebo administration 6. Procedure duration, from first needle poke to completion 7. Lidocaine levels, 5 - 15 minutes after the liposomal lidocaine cream/placebo cream is removed	—

Measure

Time frame

1. Visual Analog Scale (VAS), during venipuncture 2. Cry duration, during venipuncture 3. Heart rate, during venipuncture 4. Number of attempts until procedure completion, from first needle poke to completion 5. Endomorphins -1, -2, levels, before and 10 minutes after sucrose/sucrose placebo administration 6. Procedure duration, from first needle poke to completion 7. Lidocaine levels, 5 - 15 minutes after the liposomal lidocaine cream/placebo cream is removed

—

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026