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.: PACTR201705002301312 Date of Approval: 17/05/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of pregabalin premedication on emergence agitation in children after sevoflurane anesthesia: a randomized controlled study.
Official scientific title Effect of pregabalin premedication on emergence agitation in children after sevoflurane anesthesia: a randomized controlled study.
Brief summary describing the background and objectives of the trial Emergence agitation (EA) is as transient state that occurs while recovery from general anesthesia during which the child is irritable, restless, agitated, thrashing, crying, disoriented, or incoherent. The incidence of EA range from 10% to as high as 80%.[1] Although EA is short lived and self-limited it may cause physical harm to the child and may also last for more than 2 days [1, 2] Sevoflurane is used widely for induction and maintenance of anesthesia in children but it is associated with high incidence of EA due to rapid recovery of psychologically immature child in unfamiliar environment away from the parents, and also due to the early appearance of pain. [3,4] Numerous medications are used to prevent EA. These medications may have undesirable side effects, such as nausea and vomiting and delayed recovery after anesthesia due to excess sedation which will delay PACU discharge. [5] Pregabalin, is one of the gabapentinoid compound with anticonvulsant, analgesic, and anxiolytic activity. Our hypotheses is that giving pregabalin as premedication for children will reduce EA. The aim of the present study is to evaluate the effect of pregabalin premedication in pediatrics on EA after sevoflorane anaesthesia
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,emergence agitation in children after sevoflurane anesthesia,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/05/2017
Actual trial start date 01/05/2017
Anticipated date of last follow up 01/11/2017
Actual Last follow-up date 01/11/2017
Anticipated target sample size (number of participants) 56
Actual target sample size (number of participants) 60
Recruitment status Recruiting
Publication URL Effect of pregabalin premedication on emergence agitation in children after sevoflurane anesthesia: a randomized controlled study.
Secondary Ids Issuing authority/Trial register
31489/04/17 Research ethical committee/Faculty of medicine/Tana university/Egypt
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 Permuted block randomisation 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 pregabalin group ( Group P, ) pregabalin 1.5 mg /kg once Thirty min before induction of anesthesia patients in Group P will receive pregabalin 1.5 mg /kg dissolved in 10 cc saline while patients in Group C will reciave 10 cc saline. 30
Control Group control group ( Group C). will receive 10 cc saline once Thirty min before induction of anesthesia patients in Group C will receive 10 cc saline 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
aged 4-10 years, ASA I-II, scheduled for adenotonsillectomy under sevoflurane anaesthesia include mental or developmental retardation, allergy to the study medications hyperactivity disorders,renal or liver diseases, or use of psychiatric medications 4 Year(s) 10 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 19/04/2017 research ethical committee/faculty of medicine/ tant university
Ethics Committee Address
Street address City Postal code Country
Albahr street tanta Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary outcome will include 5 point emergence agitation scale (1= sleeping; 2= awake, calm; 3= irritable,crying; 4= inconsolable crying; 5= severe restlessness, disorientation)[ Emergency agitation will be assessed ever 10 min for 30 min postoperatively
Secondary Outcome duration of anesthesia end of anesthesia
Secondary Outcome postaneaesthesia care unit PACU length of stay before transferred to ward
Secondary Outcome postoperative analgesic requirement postoperative period
Secondary Outcome complicaltion as vomiting postoperative period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
tanta university hospital Albahr street tanta Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
tanta university hospital albahr street tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor tanta university hospital albahr street tanta Egypt University
COLLABORATORS
Name Street address City Postal code Country
Hesham Mohamed Marouf hasan radwan street,at its crossing with said kotb street, safeer building tanta Egypt
naglaa khalil yousef hasan radwan street,at its crossing with said kotb street, safeer building tanta Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator hesham marouf heshammarouf@hotmail.com 0021274366808 hasan radwan street,at its crossing with said kotb street, safeer building
City Postal code Country Position/Affiliation
tanta Egypt associate professor of anesthesia and surgical icu
Role Name Email Phone Street address
Public Enquiries naglaa khalil naglakhalil2001@gmail.com 0021273547762 hasan radwan street,at its crossing with said kotb street, safeer building
City Postal code Country Position/Affiliation
tanta Egypt lecturer of anesthesia and surgical icu
Role Name Email Phone Street address
Public Enquiries naglaa khalil naglakhalil2001@gmail.com 0021273547762 hasan radwan street,at its crossing with said kotb street, safeer building
City Postal code Country Position/Affiliation
tanta Egypt lecturer of anesthesia and surgical icu
Role Name Email Phone Street address
Scientific Enquiries hesham marouf heshammarouf@hotmail.com 0021274366808 hasan radwan street,at its crossing with said kotb street, safeer building
City Postal code Country Position/Affiliation
tanta Egypt associate professor of anesthesia and surgical icu
REPORTING
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