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.: PACTR201606001686372 Date of Approval: 18/06/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Perioperative Analgesia in Palatoplasty Surgery.
Official scientific title Surgical Site Infiltration with Dexmedetomidine or Ketamine in combination with lidocain for Perioperative Analgesia in Palatoplasty Surgery.
Brief summary describing the background and objectives of the trial Palatoplasty surgery is always associated with considerable intraoperative and postoperative pain. The aim of this study was to evaluate the perioperative analgesia after surgical site infiltration with dexmedetomidine or ketamine in combination with lidocain in children undergoing cleft palate repair surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied cleft palate repair,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 28/04/2016
Actual trial start date 28/04/2016
Anticipated date of last follow up 18/07/2016
Actual Last follow-up date 29/07/2016
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program 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 dexmedetomidine (Group D) surgical site was infiltrated with either 1 ml 2% lidocain and 1µ/kg dexmedetomidine (Group D) once surgical site was infiltrated with either 1 ml 2% lidocain and 1µ/kg dexmedetomidine (Group D) 30
Control Group ketamine (Group K) 1 ml 2% lidocain and 0.25 mg/kg ketamine once 1 ml 2%surgical site was infiltrated with lidocain and 0.25 mg/kg ketamine 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA I or II cleft palate repair Children with hypersensitivity to lidocain, ketamine or dexmedetimodine use of any other analgesic medication children of ASA Physical Class III and IV; perioperative use of any analgesics prolonged surgical procedure or extensive tissue dissection influencing the requirement of postoperative analgesia 12 Month(s) 24 Month(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 14/04/2016 ethics committee faculty of medicine alexandria university
Ethics Committee Address
Street address City Postal code Country
el azerita square Faculty of Medicine, University of Alexandria, Egypt alexandria 0000 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary outcome was the perioperative analgesia of surgical site infiltration Failure of analgesia was identified by the incidence of tachycardia and/or hypertension at any time in the intraoperative period
Secondary Outcome Children and Infants Postoperative Pain Scale (CHIPPS) were scored at recovery, every 1 hour for 4 hours then every 4 hours for 24 hrs postoperatively
Secondary Outcome Times to first cry (time taken for the child to cry after being handed to the mother in the recovery room) postoperatively
Secondary Outcome and time to feed (time taken for the child to tolerate milk feeds following the initial trial of milk feeds starting after 2 hours postoperative) postopratively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
alexandria university hospital el azerita square Faculty of Medicine, University of Alexandria, Egypt alexandria 0000 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
el Faculty of Medicine, University of Alexandria, Egypt el azerita square Faculty of Medicine, University of Alexandria, Egypt alexandria 0000 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor ola zanaty el azerita square alexandria 0000 Egypt University
COLLABORATORS
Name Street address City Postal code Country
shahira el metainy el azerita square alexandria 0000 Egypt
ola zanaty el azerita square alexandria 0000 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ola zanaty olazanaty@yahoo.com +20114880811 el azerita square
City Postal code Country Position/Affiliation
alexandria 0000 Egypt assisstent proffessor department of Anesthesia
Role Name Email Phone Street address
Public Enquiries shahira el metainy shelmetainy@yahoo.com +201223527804 el azerita square
City Postal code Country Position/Affiliation
alexandria 0000 Egypt assisstent proffessor department of Anesthesia
Role Name Email Phone Street address
Scientific Enquiries shahira el metainy shelmetainy@yahoo.com +201223527804 el azerita square
City Postal code Country Position/Affiliation
alexandria 0000 Egypt assisstent proffessor department of Anesthesia
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information