Effect of Fentanyl on Emergence Delirium (ED) on Children Undergoing Adeno-tonsilectomy at Kenyatta National Hospital (KNH)

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will be a randomized double blind placebo controlled clinical trial among children undergoing adeno-tonsillectomy in KNH. The intervention arm will comprise Fentanyl given at a dose of 1ug/while the placebo arm will be given normal saline at a volume equivalent to Fentanyl dose, treatment will be administered approximately ten minutes to the end of surgery determined by the time when the mouth gag will be removed. The main outcome will be incidence of ED at the recovery room using Watcha scale and secondary outcomes will be delay in emergence time from anaesthesia and effectiveness of fentanyl in preventing ED.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Nairobi
• Treatments: Fentanyl

Criteria

Inclusion Criteria:

• American Society of Anaesthesiologists classes (ASA) 1 and 2 children.

• ASA 1 - Normal healthy child scheduled for adeno-tonsilectomy.

• ASA 2 - Child with mild systemic disease without functional limitations.

• Children aged 1 to 12 years.

• Children undergoing elective adeno-tonsilectomy.

• Those children whose parents/guardians have given a written informed consent.

Exclusion Criteria:

• Children with genetic syndromes.

• Children with psychological/neurological behavioural disorders.

• Children with allergies to Fentanyl.

• Children with psychiatric disorders/ use of psychiatric medications.

• Use of sedative medications one hour prior to surgery.

• Children with developmental delay.

• Children coming in as day case.

• Children with airway problems not related to the surgery-sleep apnoea.

• Children less than 1 year and those above 13 years.