Fentanyl Adverse ReactionNCT04376541
Fast Tracking Impact on Fentanyl Consumption and Parents Satisfaction
An observational study of Fentanyl Adverse Reaction and Caudal Anesthesia, run by Ain Shams University.
Trial summary
The investigators are measuring fentanyl consumption in micrograms used during anesthesia for patients on fast track congenital cardiac surgeries Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- Conditions the study is for
- Fentanyl Adverse Reaction, Caudal Anesthesia
- What is being tested?
- Fentanyl
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 Apr 2020
- Phase
- Observational
- 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 3 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: patients diagnosed with congenital cardiac anomaly for surgical correction from 3months to 18 years of age
Who may be able to join
- patients diagnosed with congenital cardiac anomaly for surgical correction.
- age limit: child 3months of age to 18 years
Who cannot join
- patients with any o the following:
- emergency surgeries
- redo surgeries
- complex surgeries
- patients weight less than 3kg
About this study
Official title: Fast Tracking Impact on Fentanyl Consumption and Parents Satisfaction in Non Complex Cardiac Surgery
The investigators are measuring fentanyl consumption in micrograms used during anesthesia for patients on fast track congenital cardiac surgeries
Read the detailed description
The investigators are measuring fentanyl consumed for both fast track and conventional corrective cardiac surgeries and also parents Parental Perceptions satisfaction with early child communication in ICU and impact of caudal anesthesia on extubation time our 2ry outcomes are the hospital and ICU length of stay
- Conditions
- Fentanyl Adverse Reaction, Caudal Anesthesia
- Being tested
- Fentanyl
- Keywords
- fast track, congenital cardiac surgery, caudal, fentanyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
amount of fentanyl used in both groups
| Study group | Role | What they receive |
|---|---|---|
| early extubation | the patients extubated in O.R or within 2 hours in the ICU Receives: Drug: Fentanyl | |
| late extubation | the patients extubated after 2 hours from O.R Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
fentanyl consumption
amount of fentanyl used in microgram
Measured: during the procedure (corrective surgery)
parents satisfaction: questionnare
questionnare for parents satisfaction by early child communication
Measured: after discharge from the ICU up to 1 week
Secondary outcomes (2)
intensive care length of stay
number of days in ICU
Measured: after departure from operation room until ward discharge up to 3 weeks
hospital length of stay
total number of days spent in hospital
Measured: from admission until home discharge up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start1 Jan 2016
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fentanyl Adverse ReactionStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamal Adel Adelhameed, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04376541
- Sponsor's protocol ID
- s 43
- Status last verified
- May 2020
- First submitted
- 28 Apr 2020
- Last updated
- 6 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD Will be shared upon request
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fast Tracking Impact on Fentanyl Consumption and Parents Satisfaction in Non Complex Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04376541
- Acronym / sponsor ID
- s 43
- Conditions
- Fentanyl Adverse Reaction, Caudal Anesthesia
- Keywords
- fast track, congenital cardiac surgery, caudal, fentanyl
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 6 May 2020 (actual)
- 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 investigators are measuring fentanyl consumption in micrograms used during anesthesia for patients on fast track congenital cardiac surgeries
Detailed description
The investigators are measuring fentanyl consumed for both fast track and conventional corrective cardiac surgeries and also parents Parental Perceptions satisfaction with early child communication in ICU and impact of caudal anesthesia on extubation time our 2ry outcomes are the hospital and ICU length of stay
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early extubation | – | Drug: Fentanylthe patients extubated in O.R or within 2 hours in the ICU |
| late extubation | – | Drug: Fentanylthe patients extubated after 2 hours from O.R |
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- patients diagnosed with congenital cardiac anomaly for surgical correction from 3months to 18 years of age
Key inclusion criteria (2 listed)
- patients diagnosed with congenital cardiac anomaly for surgical correction.
- age limit: child 3months of age to 18 years
Key exclusion criteria (5 listed)
- emergency surgeries
- redo surgeries
- complex surgeries
- patients weight less than 3kg
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 |
|---|---|---|
| Fentanylamount of fentanyl used in both groups | Drug | early extubation, late extubation |
Primary outcome
fentanyl consumption
Time frame: during the procedure (corrective surgery)
amount of fentanyl used in microgram
parents satisfaction: questionnare
Time frame: after discharge from the ICU up to 1 week
questionnare for parents satisfaction by early child communication
2 secondary outcomes
intensive care length of stay
Time frame: after departure from operation room until ward discharge up to 3 weeks
hospital length of stay
Time frame: from admission until home discharge up to 4 weeks
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 6 May 2020.
- Individual participant dataSharing planned: Undecided. IPD Will be shared upon request
Related trials for Fentanyl Adverse Reaction
Not yet recruiting
Incidence of Pruritus Using Intrathecal Fentanyl Versus Epidural Fentanyl to Initiate Labour Analgesia.
Pruritis, Hypotension Drug-Induced
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?
An observational study of Fentanyl Adverse Reaction and Caudal Anesthesia, run by Ain Shams University.
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 2 inclusion and 5 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 6 May 2020. 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. 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?
fentanyl consumption (time frame: during the procedure (corrective surgery)). 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 6 May 2020.