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

University of Nairobi

Status: Completed

Conditions: Emergence Delirium

Treatments: Drug: Normal saline; Drug: Fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT02753725

UNairobi 1

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: All

Ages: 1 to 12 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

110 participants in 2 patient groups, including a placebo group

Fentanyl group

Active Comparator group

Description:

Fentanyl given at a dose of one micro gram per kilogram body weight

Treatment:

Drug: Fentanyl

normal saline group

Placebo Comparator group

Description:

placebo arm will be given normal saline at a volume equivalent to Fentanyl dose as per body weight.

Treatment:

Drug: Normal saline