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

Emergence Delirium Clinical Trial

Official title:

Effect of Fentanyl Given Approximately Ten Minutes to the End of Surgery on Emergence Delirium in Children Undergoing Adeno-tonsilectomy at Kenyatta National Hospital: A Randomized Placebo Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02753725
• Other study ID #: UNairobi 1
• Status: Completed
• Phase: N/A
• First received: April 11, 2016
• Last updated: July 15, 2016
• Start date: April 2016
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: University of Nairobi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kenya:KNH/UON-Ethics and Research Committee , UNIVERSITY OF NAIROBI,
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 12 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium

Intervention

Drug:
• Fentanyl
The intervention arm will comprise Fentanyl given at a dose of one microgram per kilogramme body weight administered approximately ten minutes to the end of surgery determined by the time when the mouth gag will be removed.
• Normal saline
the placebo arm will be given normal saline at a volume equivalent to Fentanyl dose per body weight,administered approximately ten minutes to the end of surgery determined by the time when the mouth gag will be removed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Nairobi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of patients who develop emergence delirium in both arms	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,	30 minutes	Yes
Primary	the local incidence of emergence delirium.	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.	30 minutes	Yes
Secondary	the percentage of patients developing emergence delirium in fentanyl group with 30 minutes after general anaesthesia.	the percentage of patients developing emergence delirium in both groups will be compared to determine if fentanyl prevents emergence delirium.	30 minutes	Yes
Secondary	duration of emergence time from general anaesthesia in minutes	the time taken to emerge from both arms will be compared to determine if fentanyl delays emergence time from general anaesthesia.	30 minutes	Yes