Anesthesia for Ambulatory Pediatric Surgery in Sub-Saharan Africa (SSA)

Complications Clinical Trial

Official title:

Anesthesia for Ambulatory Pediatric Surgery in Sub-Saharan Africa (SSA): a Pilot Study in Burkina Faso

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02766257
• Other study ID #: A1
• Status: Completed
• Phase: N/A
• First received: April 13, 2016
• Last updated: May 5, 2016
• Start date: June 2014

Study information

• Verified date: May 2016
• Source: Centre Hospitalier Universitaire Pédiatrique Charles de Gaulle
• Contact: n/a
• Is FDA regulated: No
• Health authority: Burkina Faso: Ministry of Health
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 15 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• non operative patients

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Complications

Intervention

Procedure:
• Anesthesia for ambulatory paediatric surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Pédiatrique Charles de Gaulle

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Failure of ambulatory surgery	number of patients that have been hospitalized (for whom ambulatory have been conversed to hospitalization)	1day	Yes
Secondary	Morbidity	Number of patients that presented complications of anesthesia or surgery such as nausea, vomiting, drowsiness and fever.	3 days	Yes
Secondary	Complication after discharge from hospital	number of phone calls from parents of patients after ambulatory discharge	3 days	No