A clinical study investigating sucrose as a pain reliever in infants

Completed

• Conditions: Pain relief following an acute noxious event in newborn infants; Signs and Symptoms

• Registration Number: ISRCTN78390996
• Lead Sponsor: niversity College London Hospitals NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-30
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. In-patients on the labour ward, post-natal ward, transitional care unit (TCU) and special care baby unit (SCBU) at the Elizabeth Garrett Anderson & Obstetrics Hospital, University College London Hospital (UCLH), UK
2. Both males and females, aged between 37 and 45 weeks post-menstrual age (PMA)
Babies will only be studied when a blood test is needed for clinical purposes.

Exclusion Criteria

Prior to each study the infant's well-being and their suitability to be studied will be assessed by the clinicians in the research group; studies will be postponed or cancelled if the infant is considered to be unfit to take part.

1. Infants who are asleep
2. Infants who are fed 30 minutes or less before the heel lance
3. Signs of tissue damage on the lower limbs
4. Intraventricular haemorrhage or periventricular leukomalacia
5. Infants who have had previous surgery
6. Infants who are receiving analgesics or sedatives
7. Infants who are born to mothers who are diabetic or opioid users
8. Infants born with congenital malformations or genetic conditions

In addition, infants that fall into the following criteria will be excluded from the study as use of 24% sucrose water is contraindicated:
9. Infants at high risk for necrotising enterocolitis
10. Asphyxiated infants
11. Infants with feeding intolerance
12. Infants without bowel sounds
13. Infants with oesophageal atresia or tracheal oesophageal fistula
14. Infants with active phase persistent pulmonary hypertension of the newborn

Study & Design

• Study Type: Interventional
• Study Design: Not specified