ComplicationsNCT02766257
Anesthesia for Ambulatory Pediatric Surgery in Sub-Saharan Africa (SSA)
A study testing Anesthesia for ambulatory paediatric surgery in people with Complications, run by Centre Hospitalier Universitaire Pédiatrique Charles de Gaulle.
Trial summary
Long surgical wait-times and limited hospital capacity are common obstacles to surgical care in many countries in sub-Saharan Africa (SSA). Ambulatory surgery might offer a solution to these problems. The aim is to study the introduction of ambulatory surgery in a pediatric hospital in SSA. Read more about this study
- Who is it for?
- Ages 1 year to 15 years
- Conditions the study is for
- Complications
- What is being tested?
- Anesthesia for ambulatory paediatric surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Nov 2014
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA 1 status
- elective surgery with low potential for blood loss or severe pain, lasting less than 90 minutes
- whose parents could be contacted by telephone and who could return to the hospital in less than 1 hour
- Parents gave consent for the surgical procedure
Who cannot join
- non operative patients
About this study
Official title: Anesthesia for Ambulatory Pediatric Surgery in Sub-Saharan Africa (SSA): a Pilot Study in Burkina Faso
Long surgical wait-times and limited hospital capacity are common obstacles to surgical care in many countries in sub-Saharan Africa (SSA). Ambulatory surgery might offer a solution to these problems. The aim is to study the introduction of ambulatory surgery in a pediatric hospital in SSA.
This is a cross-sectional descriptive study which took place over 6 months. It includes all the patients assigned to ambulatory surgery in the Pediatric University Hospital in Ouagadougou, Burkina Faso.
- Conditions
- Complications
- Being tested
- Anesthesia for ambulatory paediatric surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anesthesia for ambulatory paediatric surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| children undergoing ambulatory surgery | Other | Not described Receives: Procedure: Anesthesia for ambulatory paediatric surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure of ambulatory surgery
number of patients that have been hospitalized (for whom ambulatory have been conversed to hospitalization)
Measured: 1day
Secondary outcomes (2)
Morbidity
Number of patients that presented complications of anesthesia or surgery such as nausea, vomiting, drowsiness and fever.
Measured: 3 days
Complication after discharge from hospital
number of phone calls from parents of patients after ambulatory discharge
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2016 (estimated)
- Study startJun 2014
- Primary completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ComplicationsStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Pédiatrique Charles de Gaulle
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02766257
- Sponsor's protocol ID
- A1
- Status last verified
- May 2016
- First submitted
- 13 Apr 2016
- Last updated
- 9 May 2016
- Results posted
- No
Publications
Kabre YB, Traore IS, Kabore FA, Ki B, Traore AI, Ouedraogo I, Bandre E, Wandaogo A, Ouedraogo N. Anesthesia for Ambulatory Pediatric Surgery in Sub-Saharan Africa: A Pilot Study in Burkina Faso. Anesth Analg. 2017 Feb;124(2):623-626. doi: 10.1213/ANE.0000000000001780.
PubMed 28067703
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthesia for Ambulatory Pediatric Surgery in Sub-Saharan Africa (SSA): a Pilot Study in Burkina Faso
- ClinicalTrials.gov ID
- NCT02766257
- Acronym / sponsor ID
- A1
- Conditions
- Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire Pédiatrique Charles de GaulleUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Nov 2014 (actual)
- First posted
- 9 May 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.
Long surgical wait-times and limited hospital capacity are common obstacles to surgical care in many countries in sub-Saharan Africa (SSA). Ambulatory surgery might offer a solution to these problems. The aim is to study the introduction of ambulatory surgery in a pediatric hospital in SSA.
This is a cross-sectional descriptive study which took place over 6 months. It includes all the patients assigned to ambulatory surgery in the Pediatric University Hospital in Ouagadougou, Burkina Faso.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children undergoing ambulatory surgery | Other | Procedure: Anesthesia for ambulatory paediatric surgery |
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- ASA 1 status
- elective surgery with low potential for blood loss or severe pain, lasting less than 90 minutes
- whose parents could be contacted by telephone and who could return to the hospital in less than 1 hour
- Parents gave consent for the surgical procedure
Key exclusion criteria (1 listed)
- non operative patients
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 |
|---|---|---|
| Anesthesia for ambulatory paediatric surgery | Procedure or surgery | children undergoing ambulatory surgery |
Primary outcome
Failure of ambulatory surgery
Time frame: 1day
number of patients that have been hospitalized (for whom ambulatory have been conversed to hospitalization)
2 secondary outcomes
Morbidity
Time frame: 3 days
Complication after discharge from hospital
Time frame: 3 days
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 9 May 2016.
- Derived from this study: PubMed 28067703Kabre YB, Traore IS, Kabore FA, Ki B, Traore AI, Ouedraogo I, Bandre E, Wandaogo A, Ouedraogo N. Anesthesia for Ambulatory Pediatric Surgery in Sub-Saharan Africa: A Pilot Study in Burkina Faso. Anesth Analg. 2017 Feb;124(2):623-626. doi: 10.1213/ANE.0000000000001780.
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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 Anesthesia for ambulatory paediatric surgery in people with Complications, run by Centre Hospitalier Universitaire Pédiatrique Charles de Gaulle.
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 1 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 9 May 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. 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?
Failure of ambulatory surgery (time frame: 1day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02766257, which also lists 1 linked publication.
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 9 May 2016.