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.: PACTR201806003444426 Date of Approval: 02/06/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Analgesic effect of dexmedetimodine: Topical versus intravenous for pediatric tonsillectomy.
Official scientific title Analgesic effect of dexmedetimodine: Topical versus intravenous for pediatric tonsillectomy.
Brief summary describing the background and objectives of the trial Dexmedetimodine is an alpha2-adrenergic agonist, exhibits analgesic and anti inflammatory effects in the perioperative period. Early benefit (< 48h) of systemic Dexmedetimodine is controversed after pediatric tonsillectomy while topical Dexmedetimodine application on tonsillar bed may enhances pain relief . This study evaluates the benefit of systemic Dexmedetimodine administration and questions the topical effect.
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,pot tonsillectomy pain.,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 07/06/2018
Actual trial start date
Anticipated date of last follow up 30/08/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 326
Actual target sample size (number of participants)
Recruitment status Not yet 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
Parallel: different groups receive different interventions at same time during study Randomised simple randomisation by a randomisation table created by computer Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group A once after induction of general anesthesia patients will receive IV Dexmedetimodine 2µg/kg and local saline 163
Experimental Group Group B once after induction of general anesthesia patients will receive topical Dexmedetimodine 2µg/kg and IV saline 163
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age (8-12) years, ASA I or II known adverse reactions to DEX, mental retardation, autism, using analgesics and anticonvulsants during the perioperative period cerebral palsy. Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 2 Year(s) 12 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 16/05/2018 alexandria university hospital ethics committee
Ethics Committee Address
Street address City Postal code Country
el azeritta square alexandria 0000 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Post-operative pain evaluation at day 0, were assessed using Visual Pain Scale every 1 hour for 4 hours then every 4 hours for 24 hours postoperatively
Secondary Outcome Time to post-anesthesia awakening postoperative
Secondary Outcome time to feed postoperative
Secondary Outcome time to discharge postoperative
Secondary Outcome Hemodynamic parameters (mean blood pressure, heart rate and arterial oxygen saturation) preoperative (base line), intraoperative (after induction of anesthesia and before the regional infiltration and every 15 min) and postoperative (every 1 hr for 1st 4 hrs and every 4 hrs for 24 hrs).
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
alexandria university hospital El Azeritta aquare alexandria 0000 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
alexandria university El Azeritta aquare alexandria 0000 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor alexandria university El Azeritta aquare alexandria 0000 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Shahira ahmed youssef el metainy El Azeritta aquare alexandria 0000 Egypt
Ola Zanaty El Azeritta aquare alexandria 0000 Egypt
Tamer Ahmed Ghonim El Azeritta aquare alexandria 0000 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator shahira el metainy shelmetainy@yahoo.com +201227498438 El azzerita squARE
City Postal code Country Position/Affiliation
Alexandria 0000 Egypt Prof of anesthesia alexandria university
Role Name Email Phone Street address
Public Enquiries shahira el metainy shelmetainy@yahoo.com +201227498438 El azzerita squARE
City Postal code Country Position/Affiliation
Alexandria 0000 Egypt Prof of anesthesia alexandria university
Role Name Email Phone Street address
Scientific Enquiries shahira el metainy shelmetainy@yahoo.com +201227498438 El azzerita squARE
City Postal code Country Position/Affiliation
Alexandria 0000 Egypt Prof of anesthesia alexandria university
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