Emergence DeliriumNCT02753725
Effect of Fentanyl on Emergence Delirium (ED) on Children Undergoing Adeno-tonsilectomy at Kenyatta National Hospital (KNH)
A study testing Fentanyl and Normal saline in people with Emergence Delirium, run by University of Nairobi.
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… Read more about this study
- Who is it for?
- Ages 1 year to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Emergence Delirium
- What is being tested?
- Fentanyl and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
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
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
- Being tested
- Fentanyl, Normal saline
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
Also called treatment
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 salineDrug
Also called placebo
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
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl group | Active comparator | Fentanyl given at a dose of one micro gram per kilogram body weight Receives: 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. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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,
Measured: 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.
Measured: 30 minutes
Secondary outcomes (2)
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.
Measured: 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.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nairobi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Kirwa Elisha kiprono, University of Nairobi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02753725
- Sponsor's protocol ID
- UNairobi 1
- Status last verified
- Jul 2016
- First submitted
- 11 Apr 2016
- Last updated
- 18 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: conferences, report writing
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02753725
- Acronym / sponsor ID
- UNairobi 1
- Conditions
- Emergence Delirium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of NairobiUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 28 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fentanyl group | Active comparator | Drug: FentanylFentanyl given at a dose of one micro gram per kilogram body weight |
| normal saline group | Placebo comparator | Drug: Normal salineplacebo arm will be given normal saline at a volume equivalent to Fentanyl dose as per body weight. |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- American Society of Anaesthesiologists classes (ASA) 1 and 2 children.
- Children aged 1 to 12 years.
- Children undergoing elective adeno-tonsilectomy.
- Those children whose parents/guardians have given a written informed consent.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FentanylAlso: treatmentThe 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. | Drug | Fentanyl group |
| Normal salineAlso: placebothe 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 | Drug | normal saline group |
Primary outcome
The number of patients who develop emergence delirium in both arms
Time frame: 30 minutes
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.
Time frame: 30 minutes
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.
2 secondary outcomes
the percentage of patients developing emergence delirium in fentanyl group with 30 minutes after general anaesthesia.
Time frame: 30 minutes
duration of emergence time from general anaesthesia in minutes
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2016.
- Individual participant dataSharing planned: Yes. conferences, report writing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Fentanyl and Normal saline in people with Emergence Delirium, run by University of Nairobi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients who develop emergence delirium in both arms (time frame: 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2016.