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.: PACTR201604001572340 Date of Approval: 07/04/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of intranasal dexmedetomidine on emergence agitation
Official scientific title Effect of intranasal dexmedetomidine on emergence agitation after sevoflurane anesthesia in children undergoing tonsillectomy and/ or adenoidectomy
Brief summary describing the background and objectives of the trial Background:Emergence agitation is a self-limited problem but could lead to an inappropriate sequel which may be harmful to patients and leads to dissatisfaction and anxiety for the parents Purpose: This study investigated the safety and effectiveness of intranasal dexmedetomidine in reducing the incidence and severity of emergence agitation (EA).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Ear, Nose and Throat,Paediatrics,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 07/10/2015
Actual trial start date 03/11/2015
Anticipated date of last follow up 03/01/2016
Actual Last follow-up date 01/02/2016
Anticipated target sample size (number of participants) 86
Actual target sample size (number of participants) 86
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 Computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group D Received intranasal dexmedetomidine at 1µg/ kg 43
Control Group group C Received intranasal saline 0.9% after induction of general anesthesia. 43 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA I and II physical status. Ages ranged between 3-7 years old. Scheduled for an elective tonsillectomy and/ or adenoidectomy under general anaesthesia with sevoflurane. Obstructive sleep apnea. Mental retardation or developmental delay. Chest, cardiac or neurological diseases. Known allergy or hypersensitivity to dexmedetomidine. Patients receiving medications known to interact with dexmedetomidine such as furosemide, lorazepam, and diphenhydramine 3 Year(s) 7 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 28/10/2015 Benha faculty of medicine
Ethics Committee Address
Street address City Postal code Country
Farid Nada st. Benha 230280 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Four-point agitation scale After extubation
Secondary Outcome FLACC scale score for pain assessment were measured at six-time points measured at six-time points after extubation, leaving the operating room, on arrival to PACU, 10, 20, and 30 min after arrival in PACU
Secondary Outcome Adverse effects Postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Benha faculty of medicine Farid Nada st. Benha 230280 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Benha university Farid Nada st. Benha 230280 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Benha university hospitals Farid Nada st. Benha 230280 Egypt Hospital
Primary Sponsor Benha university Farid Nada st Benha 230280 Egypt University
COLLABORATORS
Name Street address City Postal code Country
ENT department Farid Nada st. Benha 230280 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Mostafa Abd El-Hamid bashaahmad@yahoo.com +201005204130 20 Ezz Eldin Omar st.
City Postal code Country Position/Affiliation
Giza 12111 Egypt Assistant professor
Role Name Email Phone Street address
Public Enquiries Hany Mahmoud Yassin hmy00@fayoum.edu.eg +201111363602 303 T Hadaiek Elahram
City Postal code Country Position/Affiliation
Giza 12572 Egypt Lecturer
Role Name Email Phone Street address
Scientific Enquiries Saad Ibrahim Saad saadibrahim_7@yahoo.com +1223142889 Oman st. Eldoqqi
City Postal code Country Position/Affiliation
Giza Egypt Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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