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

Not Applicable

Completed

• Conditions: Emergence Delirium
• Interventions: Drug: Fentanyl; Drug: Normal saline

• Registration Number: NCT02753725
• Lead Sponsor: University of Nairobi

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-11
• Study First Submitted QC: 2016-04-25
• Study First Posted: 2016-04-28
• Status Verified: 2016-07
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Last Update Submitted: 2016-07-15
• Last Update Posted: 2016-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fentanyl group	Fentanyl	Fentanyl given at a dose of one micro gram per kilogram body weight
normal saline group	Normal saline	placebo arm will be given normal saline at a volume equivalent to Fentanyl dose as per body weight.

Primary Outcome Measures

Name	Time	Method
The number of patients who develop emergence delirium in both arms	30 minutes	the number of patients who develop emergence delirium within 30 minutes after general anaesthesia will be assessed using Watcha scale indicated in the study questionnaire,
the local incidence of emergence delirium.	30 minutes	local incidence of emergence delirium will be determined by the percentage of those who develop emergence delirium in the placebo group within 30 minutes after general anesthesia as assessed by Watcha scale.

Secondary Outcome Measures

Name	Time	Method
the percentage of patients developing emergence delirium in fentanyl group with 30 minutes after general anaesthesia.	30 minutes	the percentage of patients developing emergence delirium in both groups will be compared to determine if fentanyl prevents emergence delirium.
duration of emergence time from general anaesthesia in minutes	30 minutes	the time taken to emerge from both arms will be compared to determine if fentanyl delays emergence time from general anaesthesia.