AgitationNCT01440114
The Effect of Intravenous Fentanyl Prior the End of Surgery on Emergence Agitation in Paediatric Patients After General Anesthesia
A study testing fentanyl and NSS in people with Agitation, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
The propose of this study is to determine the effect of intravenous fentanyl prior the end of surgery on the incidence and severity of EA in pediatric patient. Read more about this study
- Who is it for?
- Ages 2 to 9 years
- Conditions the study is for
- Agitation
- What is being tested?
- fentanyl and NSS
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2010to Jul 2011
- 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 2 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged between 2-9 years
- IPD patient
- Receiving Chloral hydrate 50mg/kg (BW<20 kgs)or midazolam 0.1 mg /kg (BW>20 kgs)Per oral for premedication
- Scheduled for one kind of these surgeries; Otolaryngology, Ophthalmology, Urology, Orthopedic,General surgery, Plastic surgery and Cardiac catheterization.
Who cannot join
- ASA physical status IV-V
- History of drug allergy:thiopental, fentanyl cisatracurium, chloral hydrate and diazepam
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine, Prince of Songkla University
Hat Yai, Changwat Songkhla, 90110
About this study
The propose of this study is to determine the effect of intravenous fentanyl prior the end of surgery on the incidence and severity of EA in pediatric patient.
Read the detailed description
Emergence agitation (EA) is a common self limiting problem after emerging from general anesthesia (GA) especially in pediatric patients. The incidence of EA in Thai population, the incidences of EA 43.2% in pediatric patients aged between 2-9 years. There have been many studies tried to reduce the incidence of EA in various ways such as Preoperative anxiety reduction method and medication. Premedication, Sedative drugs and narcotic drugs were used to reduce the incidence of EA.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fentanylDrug
In intervention group patient received fentanyl 1 mcg/kg intravenous 15 minutes before the end of surgery.
NSSDrug
Patient in this group received NSS (0.1ml/kg)intravenous route 15 minutes before the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| fentanyl group | Active comparator | First arm: intervention group. Patient in this group received fentanyl 1 mcg/kg (concentration 10mcg/ml) intravenous route 15 minutes before the end of surgery. Receives: Drug: fentanyl |
| controlled group | Placebo comparator | patient in this group received NSS 0.1 ml/kg 15 minutes before the end of surgery Receives: Drug: NSS |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of emergence agitation
Measured: pt was observed since emerging from anesthesia up to 60 minutes
Secondary outcomes (3)
severity of emergence agitation
Measured: pt was observed since emerging from anesthesia up to 60 minutes
adverse effect from intravenous fentanyl prior the end of surgery
Measured: pt was observed since emerging from anesthesia upto 60 minutes
post operative pain
Measured: pt was observed since emerging from anesthesia up to 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2011 (estimated)
- Study startMar 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgitationStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ngamjit Pattaravit, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01440114
- Sponsor's protocol ID
- PSUEA1
- Status last verified
- Sep 2011
- First submitted
- 22 Sep 2011
- Last updated
- 26 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intravenous Fentanyl Prior the End of Surgery on Emergence Agitation in Paediatric Patients After General Anesthesia
- ClinicalTrials.gov ID
- NCT01440114
- Acronym / sponsor ID
- PSUEA1
- Conditions
- Agitation
- Keywords
- emergence agitation, pediatric patient, fentanyl, incidence of emergence agitation, severity of emergence agitation, adverse outcome from intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 26 Sep 2011 (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.
The propose of this study is to determine the effect of intravenous fentanyl prior the end of surgery on the incidence and severity of EA in pediatric patient.
Detailed description
Emergence agitation (EA) is a common self limiting problem after emerging from general anesthesia (GA) especially in pediatric patients. The incidence of EA in Thai population, the incidences of EA 43.2% in pediatric patients aged between 2-9 years. There have been many studies tried to reduce the incidence of EA in various ways such as Preoperative anxiety reduction method and medication. Premedication, Sedative drugs and narcotic drugs were used to reduce the incidence of EA.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fentanyl group | Active comparator | Drug: fentanylFirst arm: intervention group. Patient in this group received fentanyl 1 mcg/kg (concentration 10mcg/ml) intravenous route 15 minutes before the end of surgery. |
| controlled group | Placebo comparator | Drug: NSSpatient in this group received NSS 0.1 ml/kg 15 minutes before the end of surgery |
Who may qualify
- Ages
- 2 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Aged between 2-9 years
- IPD patient
- Receiving Chloral hydrate 50mg/kg (BW<20 kgs)or midazolam 0.1 mg /kg (BW>20 kgs)Per oral for premedication
- Scheduled for one kind of these surgeries; Otolaryngology, Ophthalmology, Urology, Orthopedic,General surgery, Plastic surgery and Cardiac catheterization.
Key exclusion criteria (2 listed)
- ASA physical status IV-V
- History of drug allergy:thiopental, fentanyl cisatracurium, chloral hydrate and diazepam
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 |
|---|---|---|
| fentanylIn intervention group patient received fentanyl 1 mcg/kg intravenous 15 minutes before the end of surgery. | Drug | fentanyl group |
| NSSPatient in this group received NSS (0.1ml/kg)intravenous route 15 minutes before the end of surgery. | Drug | controlled group |
Primary outcome
the incidence of emergence agitation
Time frame: pt was observed since emerging from anesthesia up to 60 minutes
3 secondary outcomes
severity of emergence agitation
Time frame: pt was observed since emerging from anesthesia up to 60 minutes
adverse effect from intravenous fentanyl prior the end of surgery
Time frame: pt was observed since emerging from anesthesia upto 60 minutes
post operative pain
Time frame: pt was observed since emerging from anesthesia up to 60 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 26 Sep 2011.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fentanyl and NSS in people with Agitation, run by Prince of Songkla University at 1 site in Thailand.
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 4 inclusion and 2 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 26 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
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 incidence of emergence agitation (time frame: pt was observed since emerging from anesthesia up to 60 minutes). 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 26 Sep 2011.