Back to resultsEffect of Fentanyl on Emergence Delirium (ED) on Children Undergoing Adeno-tonsilectomy at Kenyatta National Hospital (KNH)
Primary Purpose
Emergence Delirium
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fentanyl
Normal saline
Sponsored by
About this trial
This is an interventional prevention trial for Emergence Delirium
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Fentanyl group
normal saline group
Arm Description
Fentanyl given at a dose of one micro gram per kilogram body weight
placebo arm will be given normal saline at a volume equivalent to Fentanyl dose as per body weight.
Outcomes
Primary Outcome Measures
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,
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02753725
Brief Title
Effect of Fentanyl on Emergence Delirium (ED) on Children Undergoing Adeno-tonsilectomy at Kenyatta National Hospital (KNH)
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nairobi
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergence Delirium
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fentanyl group
Arm Type
Active Comparator
Arm Description
Fentanyl given at a dose of one micro gram per kilogram body weight
Arm Title
normal saline group
Arm Type
Placebo Comparator
Arm Description
placebo arm will be given normal saline at a volume equivalent to Fentanyl dose as per body weight.
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Other Intervention Name(s)
treatment
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
The number of patients who develop emergence delirium in both arms
Description
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,
Time Frame
30 minutes
Title
the local incidence of emergence delirium.
Description
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.
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
the percentage of patients developing emergence delirium in fentanyl group with 30 minutes after general anaesthesia.
Description
the percentage of patients developing emergence delirium in both groups will be compared to determine if fentanyl prevents emergence delirium.
Time Frame
30 minutes
Title
duration of emergence time from general anaesthesia in minutes
Description
the time taken to emerge from both arms will be compared to determine if fentanyl delays emergence time from general anaesthesia.
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
conferences, report writing
Learn more about this trial
Effect of Fentanyl on Emergence Delirium (ED) on Children Undergoing Adeno-tonsilectomy at Kenyatta National Hospital (KNH)
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