Does prewarming children improve outcomes in children with cerebral palsy having major lower limb surgery?

• Register: ANZCTR
• Last refreshed on: 22 February 2013
• Main ID: ACTRN12609000297224
• Date of registration: 18/05/2009
• Primary sponsor: Hospital Royal Children's Hospital
• Public title: Does prewarming children improve outcomes in children with cerebral palsy having major lower limb surgery?
• Scientific title: A randomised study assessing the effect of prewarming on outcomes of children with cerebral palsy undergoing orthopaedic surgery to prevent hypothermia
• Date of first enrolment: 30/03/2009
• Target sample size: 80
• Recruitment status: Not yet recruiting
• URL: http://www.anzctr.org.au/ACTRN12609000297224.aspx
• Study type: Interventional
• Study design: Randomised controlled trial Parallel

Countries of recruitment

Australia

Contacts

• Name: Dr Stefan Sabato

• Name: Suzette Sheppard

Key inclusion & exclusion criteria

Inclusion criteria: 1)Children with severe cerebral palsy undergoing elective bilateral femoral valgus derotational osteotomies
2) Children aged between 5 -20 years
3) Any weight
Exclusion criteria: 1) Any contraindication to inhaled anaesthetic agents (desflurane/nitrous oxide) (eg: malignant hyperthermia)
2) Severe comorbidities that require postoperative admission to intensive care.
3) Contraindications to epidural anaesthesia
(eg: iatrogenic or pathological coagulopathy or platelet dysfunction, local Sepsis, parental refusal to consent)
3) Ambient room temperature > 28 degrees in the pre-surgical centre

Age minimum: 5 Years
Age maximum: 20 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Children with severe cerebral palsy undergoing elective bilateral femoral valgus derotational osteotomies

Intervention(s)

The intervention is for patients to lie in a bed and be prewarmed with a forced air warming blanket set at 40 degrees for one hour prior to induction of anaesthesia.

Primary Outcome(s)

To determine whether prewarming can prevent hypothermia. Skin temperature and core temperature (tympanic) will be measured pre and post anaesthesia. During anaesthesia, temperature will be measured using an oesophageal temperature probe.

Secondary Outcome(s)

To determine whether effects the rate of wound infections. Wounds will be classified as infected if there was a purulent discharge or painful erythema that lasted for 5 days and was treated with antibiotics within 6 weeks of surgery.

To determine whether prewarming effects the amount of surgical blood loss. To assess intraoperative and postoperative blood loss we will use (a) Weighing packs, (b) Measuring Drains and (c) Haemoglobin Balance method.

To determine whether prewarming effects the duration of recovery from anaesthesia.

Source(s) of Monetary Support

Royal Children's Hospital