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

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

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.

Study Overview

• Status: Completed
• Conditions: Emergence Delirium
• Intervention / Treatment: Drug: Fentanyl; Drug: Normal saline

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fentanyl group; Fentanyl given at a dose of one micro gram per kilogram body weight	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.; Other Names: treatment
Placebo Comparator: normal saline group; placebo arm will be given normal saline at a volume equivalent to Fentanyl dose as per body weight.	Drug: 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; Other Names: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Nairobi

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: April 11, 2016
• First Submitted That Met QC Criteria: April 25, 2016
• First Posted (Estimate): April 28, 2016

Study Record Updates

• Last Update Posted (Estimate): July 18, 2016
• Last Update Submitted That Met QC Criteria: July 15, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Emergence Delirium; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl
• Other Study ID Numbers: UNairobi 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: conferences, report writing