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

NCT02753725 | Completed DMC

• 1 other identifier: UNairobi 1
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Emergence Delirium

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (2)

• the percentage of patients developing emergence delirium in fentanyl group with 30 minutes after general anaesthesia.

  30 minutes

• duration of emergence time from general anaesthesia in minutes

  30 minutes

Study Arms (2)

Fentanyl group

ACTIVE COMPARATOR

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

Drug: Fentanyl

normal saline group

PLACEBO COMPARATOR

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

Drug: Normal saline

Interventions

Fentanyl DRUG

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.

Also known as: treatment

Fentanyl group

Normal saline DRUG

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

Also known as: placebo

normal saline group

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nairobi: lead

MeSH Terms

Conditions

Emergence Delirium

Interventions

Fentanyl; Therapeutics; Saline Solution

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: April 11, 2016
• First Posted: April 28, 2016
• Study Start: April 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 18, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will share