Remifentanil Tapering and Post-adenotonsillectomy Pain in Children: a Randomised, Placebo Controlled, Double Blind Study

2019-001677-81

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).

2020-01-16

2023-08-18

2023-08-18

Terminated

Early phase I

6

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double blind, randomised, placebo controlled trial.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Two syringes will be simultaneously infused during the operation. One will contain normal saline solution and the other remifentanil solution. Prior to the end of the operation one of the syringes will have a step wise decrease in infusion rate whilst the other will be abruptly stopped at the end of surgery.\n\nThe syringes will be prepared according to randomisation in the hospital pharmacy and the identity of each syringe will be masked from all those involved in the study. The syringe randomisation will be de-coded following completion of recruitment.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 6, 'type': 'ACTUAL'}}

2023-08-22