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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202402880294495 Date of Registration: 01/02/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of oral melatonin versus oral ketamine on the incidence of emergence delirium in children undergoing squint surgery: A prospective randomized controlled trial
Official scientific title Effect of oral melatonin versus oral ketamine on the incidence of emergence delirium in children undergoing squint surgery: A prospective randomized controlled trial
Brief summary describing the background and objectives of the trial Emergence delirium is common in preschool children after general anesthesia with sevoflurane. (1) Apart from being an unpleasant and distressing experience for the children and their parents, emergence delirium may result in inadvertent injury, dislodgement of the intravenous cannula, suture dehiscence and a rise in intraocular pressure. The latter is of particular importance following ocular procedures, which represent a high-risk group for emergence delirium. Inadequately managed emergence delirium has also been associated with increased postoperative nursing-care related costs, prolonged stay in the post- anesthesia care unit (PACU) and delayed hospital discharge after uncomplicated surgery. (2) Melatonin is a natural sleep promoting neurohormone synthesized within the pineal gland. Aside from regulation of circadian rhythm, melatonin’s physiological functions include antioxidant, oncostatic, anti-inflammatory and anticonvulsant effects. (3) Melatonin is used in children and neonates to manage a number of conditions, including sleep and seizure disorders and neonatal sepsis. Melatonin has also been evaluated for its use as a pre-operative anxiolytic and has promising potential due to its reduced sedative effect. compared to other anxiolytics. Melatonin’s anxiolytic properties are considered to be a consequence of its facilitatory role on γ-aminobutyric acid (GABA) transmission. (4) Ketamine is an effective drug for sedation, analgesia and amnesia. (5) Administration of ketamine orally as preoperative medication to patients was proved to decrease the incidence of emergence agitation without a delay in recovery. (6) The aim of this study is to assess the effect of oral melatonin versus oral ketamine on the incidence of emergence delirium in children scheduled for squint surgery under sevoflurane.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PEDIATRIC EMERGENCE DELERIUM
Disease(s) or condition(s) being studied Anaesthesia,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 26/09/2023
Actual trial start date 01/10/2023
Anticipated date of last follow up 26/02/2024
Actual Last follow-up date 01/03/2024
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 90
Recruitment status Recruiting
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group placebo 5 ml 45 minutes before induction of anesthesia will receive Plain honey (5 ml) will be used as placebo. 30 Placebo
Experimental Group oral melatonin The children will receive either oral melatonin 0.3 mg/kg 45 minutes before induction of anesthesia The children will receive either oral melatonin 0.3 mg/kg 30
Experimental Group oral ketamine Oral ketamine will be reconstituted by mixing the calculated dose of intravenous ketamine in 5 ml of plain honey. Plain honey (5 ml) will be used as placebo. The calculated dose will be prepared and administered 45 min prior to anesthesia induction in a 5 ml syringe by an anesthesia resident who will not be involved in the conduct of the anesthesia or the assessment of study outcomes 45 minute before induction of anesthesia Oral ketamine will be reconstituted by mixing the calculated dose of intravenous ketamine in 5 ml of plain honey. Plain honey (5 ml) will be used as placebo. The calculated dose will be prepared and administered 45 min prior to anesthesia induction in a 5 ml syringe by an anesthesia resident who will not be involved in the conduct of the anesthesia or the assessment of study outcomes 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children aged 3 to 5 years with American Society of Anesthesiologists Physical Status I or II scheduled for squint surgery will be enrolled in the study. neurological disease neurodevelopmental anomalies mental retardation hearing impairment Preschool Child: 2 Year-5 Year 3 Year(s) 5 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 23/09/2023 research ethics committee
Ethics Committee Address
Street address City Postal code Country
elgeish street tanta 1111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome incidence of emergence delirium at the time of arrival to the PACU and then at 10, 20, 30, 45 and 60
Secondary Outcome : parent separation and postoperative sedation, postoperative pain the PACU and then at 10, 20, 30, 45 and 60 min after arrival.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
facuty of medicine tanta university elgeish street tanta 1111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
deparmental resouces elgeish street tanta 1111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine tanta university elgeish street tanta 1111 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Gehan Morsy Eid 7 thawat street tanta 4455 Egypt
Shaimaa Farouk Abd Elkader Mostafa 15 MOHEB STREET ELMAHLA ELKOBRA 2233 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator GEHAN EID gehan2552011@gmail.com 00201226010410 7 tharwat street
City Postal code Country Position/Affiliation
tanta 4455 Egypt assistant professor
Role Name Email Phone Street address
Public Enquiries shaimaa mostafa shaimaafarouk7777@yahoo.com 00201270440771 moheb street
City Postal code Country Position/Affiliation
elmahala elkobra 2233 Egypt assistant professor
Role Name Email Phone Street address
Scientific Enquiries mohamed aboelyazed moh_yaed75@yahoo.com 00201120014472 elestad street
City Postal code Country Position/Affiliation
tanta 7777 Egypt professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes the data associated with the paper are not publicly available but are available from the corresponding author on reasonable request. Data will be available for 6 months after the manuscript is accepted for publication. Clinical Study Report,Informed Consent Form,Study Protocol 6 monthes Any unexpected risks appear during the course of the research will be cleared to the participants and ethical committee on time and proper measures will be taken.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information