Oral Glucose Solution as Pain Relief in Newborns: Results of a Clinical Trial
This trial is active, not recruiting.
|Treatments||glucose 10%, 20% glucose, glucose 30%, sterile water|
|Start date||November 2007|
|End date||April 2009|
|Trial size||304 participants|
|Trial identifier||NCT00847028, (EC NR 7/37/203)., HHmol-001|
This study investigates which concentration of glucose is most effective in reducing pain for venipuncture in the newborn.
|Endpoint classification||efficacy study|
|Intervention model||factorial assignment|
|Masking||double blind (subject, caregiver, investigator)|
|Primary purpose||supportive care|
Pain after venipuncture measured by the Leuven pain scale for newborns
time frame: solution administration- waiting for 2 minutes-then venipuncture and immediate pain scoring
difference in heart rhythm
time frame: heart rhythm measured before painful procedure - heart rythm after venipuncture compared to baseline measurement
Male or female participants of any age.
Inclusion criteria - Neonates were included if they had to undergo a venipuncture as part of routine medical care. Exclusion criteria - Unstable neonates with respiratory support as well as neonates with a proven neurological abnormality were excluded. - Newborns who had been administered sedatives, analgesics or naloxone during the past 48 hours were excluded along with premature infants younger than 32 weeks post menstrual age.
|Official title||Oral Glucose Solution as Pain Relief in Newborns: Results of a Clinical Trial|
|Principal investigator||Ben Dilen, MSN|
|Description||This double-blind clinical trial is conducted on a maternity and newborn (N*) ward. Each time, during at least one month, one of the four selected solutions (glucose 10%, 20%, 30% and placebo) will be administered orally, 2 minutes prior to the venipuncture. The pain from the skin puncture will be scored using a validated pain scale (the "Leuven" pain scale).|
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