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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Emergence Delirium

Intervention / Treatment
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* Drug: Fentanyl
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 |