Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202205734825652 Date of Approval: 04/05/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effects of ketamine-fentanyl and propofol-fentanyl combinations on LMA insertion conditions in Nigerian children undergoing day-case herniotomy: a randomized controlled trial
Official scientific title Effects of ketamine-fentanyl and propofol-fentanyl combinations on LMA insertion conditions in Nigerian children undergoing day-case herniotomy: a randomized controlled trial
Brief summary describing the background and objectives of the trial Abstract Background: Propofol is used as an induction agent to facilitate laryngeal mask airway (LMA) insertion, but unwanted responses such as drop in blood pressure, cough, laryngospasm, movement and apnoea may occur. Use of propofol with adjuvant or a combination of different synergistic pharmacologic agents that can maintain airway patency and hemodynamic parameters can be exploited to avoid these undesirable responses and effects during LMA insertion. We compared the effects of ketamine-fentanyl and propofol-fentanyl combinations on LMA insertion conditions and post-operative outcome in children undergoing herniotomy. Methods: The study was double-blinded and conducted on eighty ASA physical statuses I and II paediatric patients within the age of 1 and 15years scheduled for herniotomy. The patients were randomized into two groups (A and B) of forty patients each and LMA was inserted following administrations of two different drug combinations. Group A received pre-mixed ketamine 2mg/kg and fentanyl 2µg/kg while group B received pre-mixed propofol 2.5mg/kg and fentanyl 2µg/kg. The quality of response to LMA placement (LMA insertion conditions) and post-operative outcome (patient recovery) was assessed. Results: The number of patients with acceptable LMA insertion conditions were comparable in both groups, p=1.000, while incidence of apnoea was significantly greater in propofol-fentanyl group, p=0.045 with no difference in the post anaesthesia discharge scores between the groups, p=0.241. Conclusion: Intravenous ketamine-fentanyl combination is a better induction agent for LMA insertion in children with acceptable LMA insertion conditions, good post-operative recovery scores and lower incidence of peri-insertion apnoea when compared with propofol-fentanyl combination. AIM AND OBJECTIVES Aim: The aim of the study was to compare effects of ketamine-fentanyl and propofol-fentanyl combinations on LMA insertion conditions in Nigerian children undergoing day-case herniotomy. Specific Objectives: 1. To determine the LMA insertion conditions (mouth opening, coughing, swallowing, movement, laryngospasm & ease of insertion) in children induced with ketamine-fentanyl combination for LMA insertion before herniotomy. 2. To determine the LMA insertion conditions in children induced with propofol-fentanyl combination for LMA insertion before herniotomy. 3. To determine the incidence of apnoea in both groups. 4. To determine the post anaesthesia discharge score.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 10/01/2016
Actual trial start date 29/09/2016
Anticipated date of last follow up 10/03/2017
Actual Last follow-up date 28/06/2017
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group RCT Patients in group A were assigned to receive intravenous ketamine-fentanyl (2mg/kg & 2µg/kg respectively) combination Statum dose The study was double-blinded and conducted on eighty ASA physical statuses I and II paediatric patients within the age of 1 and 15years scheduled for herniotomy. The patients were randomized into two groups (A and B) of forty patients each and LMA was inserted following administrations of two different drug combinations. Group A received pre-mixed ketamine 2mg/kg and fentanyl 2µg/kg while group B received pre-mixed propofol 2.5mg/kg and fentanyl 2µg/kg. The quality of response to LMA placement (LMA insertion conditions) and post-operative outcome (patient recovery) was assessed. 40
Control Group RCT Group B were assigned to receive intravenous propofol-fentanyl (2.5mg/kg & 2µg/kg respectively Statum dose The study was double-blinded and conducted on eighty ASA physical statuses I and II paediatric patients within the age of 1 and 15years scheduled for herniotomy. The patients were randomized into two groups (A and B) of forty patients each and LMA was inserted following administrations of two different drug combinations. Group A received pre-mixed ketamine 2mg/kg and fentanyl 2µg/kg while group B received pre-mixed propofol 2.5mg/kg and fentanyl 2µg/kg. The quality of response to LMA placement (LMA insertion conditions) and post-operative outcome (patient recovery) was assessed. 40 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
INCLUSION CRITERIA 1. All consenting/assenting patients between the ages of 1 and 15years scheduled for elective herniotomy procedure under general anaesthesia. 2. American Society of Anesthesiologists’ (ASA) physical status class I and II patients. EXCLUSION CRITERIA 1. Patients with history of allergic reactions to propofol, ketamine and fentanyl. 2. Patient refusal to participate/parent's and guidance failure to give assent. 3. Patients American Society of Anesthesiologists’ (ASA) physical status greater than II. 4. All patients with clinically significant cardiovascular, respiratory, hepatic and renal diseases. 5. Patients currently taking sedative or analgesic drugs. 6. Difficulty with communication/language barrier. 7. Patients with mental illness. 8. Patients with oropharyngeal pathology. 9. Patients with hiatus hernia. 10. Patients with respiratory tract infection. 11. Patients with history of seizure disorder. 12. Patients with raised intracranial or intraocular pressure. 13. Anatomical abnormality of the airway. 14. Patients at risk of aspiration. 15. Patients with hyperactive airway. Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year,Infant: 0 Month-23 Month,Infant: 1 Month-23 Month,Preschool Child: 2 Year-5 Year 1 Year(s) 15 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 29/09/2016 University of Ilorin Teaching Hospital Ethical Research Committee
Ethics Committee Address
Street address City Postal code Country
Old Jebba Road, Oke Ose, Ilorin Ilorin 240101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Post anaesthetic discharge score was assessed as secondary outcome measure. Post Anaesthesia discharge score was assessed at the end of surgery
Primary Outcome Laryngeal mask airway insertion conditions and incidence of apnoea were assessed as primary outcome measures LMA insertion conditions were measured during LMA insertion, while apnoea was measured immediately after LMA insertion
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Ilorin Teaching hospital Oke-Oyi Ilorin 240101 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Okeyemi Ajibade Federal Medical Centre, Owo Owo 341101 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Authors Federal Medical Centre, Owo Owo 341101 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr. Okeyemi Ajibade Federal Medical Centre, Owo Owo 341101 Nigeria
Dr. Suleiman Zakari Aliyu University of Ilorin Teaching Hospital Ilorin 240101 Nigeria
Dr. Oyedepo Olanrewaju Olubukola University of Ilorin Teaching Hospital Ilorin 240101 Nigeria
Prof. Bolaji Benjamin Olusomi University of Ilorin Teaching Hospital Ilorin 240101 Nigeria
Dr. Akere Abidemi David Federal Medical Centre, Owo Owo 341101 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Suleiman Zakari Aliyu suzack71@yahoo.com +2348064046040 University of Ilorin Teaching Hospital
City Postal code Country Position/Affiliation
Ilorin 240101 Nigeria Consultant Anaesthetist
Role Name Email Phone Street address
Scientific Enquiries Bolaji Benjamin Olusomi olubolajidr@yahoo.com +2348033615810 University of Ilorin Teaching Hospital
City Postal code Country Position/Affiliation
Ilorin 240101 Nigeria Professor of Anaesthesia
Role Name Email Phone Street address
Public Enquiries Akere Abidemi David demiakere@yahoo.com +2348063103200 Federal Medical Centre
City Postal code Country Position/Affiliation
Owo 341101 Nigeria Consultant Anaesthetist
Role Name Email Phone Street address
Principal Investigator Okeyemi Ajibade talktorhymes@yahoo.com +2348060418129 Federal Medical Centre
City Postal code Country Position/Affiliation
Owo 240101 Nigeria Consultant Anaesthetist and Intensivist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Will individual participant data be available (including data dictionaries): yes Study Protocol No end date No end date
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 27/04/2022
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 27/04/2022
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information