Remifentanil Tapering and Post-adenotonsillectomy Pain in Children

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Tonsillectomy is the commonest operation of childhood and results in considerable pain.

Remifentanil is a potent, ultra short acting opioid with a long- established safety record in paediatric anaesthesia that is used to provide intraoperative analgesia.

There is evidence from adult studies that remifentanil increases postoperative pain, although this may be ablated if propofol (rather than inhalational anaesthesia) is used or if the remifentanil is tapered rather than abruptly discontinued at the end of surgery.

The analgesic effect of gradual withdrawal of remifentanil at the end of surgery has not been studied in children and may have significant clinical implications.

The primary measure of efficacy will be the dose of fentanyl rescue analgesia in the peri-operative period (1 mcg.kg-1 bolus for >20% increase in pulse, blood pressure or movement intraoperatively or a FLACC(Face, Legs, Arms, Cry, Consolablity) score of >5 in recovery).

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospital, Akershus
• Treatments: Remifentanil

Criteria

Inclusion Criteria:

• American Society Anaesthesiology I-II children 1 to 10 years

• Weight over 10.0 Kg

• Presenting for tonsillotomy / tonsillectomy or adenotonsillectomy at Akershus Universitetssykehus, Lørenskog and Lovisenberg Diakonale Hospital, Norway

Exclusion Criteria:

• Children who have had airway surgery previously.

• Children who have had any type of surgery in the previous 12 months.

• Children using chronic pain medication or who have used analgesia in the 24 hours preceding surgery.

• Children who are known to suffer from NSAID sensitive asthma.

• Children with a known allergy to propofol or remifentanil.

• Pre-existing cardiac, renal, liver dysfunction.

• Children or parents who are not fluent in Norwegian or English.

• Children in whom more than three attempts at intravenous cannulation are required or in those who request an inhalational induction or premedication