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.: PACTR202111603969039 Date of Approval: 17/11/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title prevention of emergence agitation in children by adding Ketamine or midazolam to bupivacaine caudally
Official scientific title ketamine versus midazolam as adjuvant to caudal bupivacaine for prevention of emergence agitation in children a prospective randomized comparative study
Brief summary describing the background and objectives of the trial Emergence agitation (EA), which is also referred to as emergence delirium in children is a major postoperative issue that increases the risk of patient self harm ,places a burden on nursing staff, and reduces parent satisfaction with treatment The definition of EA is “a disturbance in a child’s awareness of and attention to his or her environment with disorientation and perceptual alterations, including hypersensitivity to stimuli and hyperactive motor behavior in the immediate post-anesthesia period.” Risk factors for EA include age, preoperative anxiety, patient personality, pain, anesthesia method, and surgical procedure. In cases of EA, patients often remove drains or catheters, causing self-harm. Thus, sedation or restraint by health care providers may be required. Furthermore, this EA is often a particularly unpleasant experience for parents or caregivers. Therefore, various approaches allowing uneventful emergence from anesthesia have been studied. Ketamine and Midazolam both are being used to prevent EA in children mainly through intravenous route. The primary outcome of this study is prevention of EA this outcome will be measured by the pediatric anesthesia emergence delirium scale (PAED). The secondary outcomes are post operative analgesia which will be determined by the face legs activity cry consolability scale (FLACC), time of first analgesic request, 24 hours postoperative analgesic requirement and intraoperative hemodynamics.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 25/11/2020
Actual trial start date 15/03/2021
Anticipated date of last follow up 25/11/2021
Actual Last follow-up date 20/01/2022
Anticipated target sample size (number of participants) 46
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 randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group caudal block adding ketamine or midazolam to the local anesthetic used which is bupivacaine bupiacaine 0.25 \ 0.5ml\kg kitamine 0.5 mg\kg once In the operating room,standard monitoring , which will be composed of electrocardiography, pulse oximetry, heart rate, and noninvasive arterial blood pressure (NIBP) will be started. After induction of general anesthesia with sevoflurane a peripheral IV line will be secured and securing the airway with tracheal tube, Anesthesia will be maintained using Oxygen/air/sevoflurane 1.5-2.5% mixture. No intraoperative intravenous analgesic will be administered in any child . thereafter the patient will be turned into the left lateral position and caudal blockade will be achieved under sterile conditions using a 22 gauge short beveled needle . bupivacaine 0.25 at the volume of 0.5 ml/kg will be administered in combination of Ketamine 0.5mg/kg 23
Control Group caudal block adding midazolam to the local anesthetic agent bupivacaine 0.25% 0.5 ml\kg midazolam 50 ug\kg once In the operating room,standard monitoring , which will be composed of electrocardiography, pulse oximetry, heart rate, and noninvasive arterial blood pressure (NIBP) will be started. After induction of general anesthesia with sevoflurane a peripheral IV line will be secured and securing the airway with tracheal tube, Anesthesia will be maintained using Oxygen/air/sevoflurane 1.5-2.5% mixture. No intraoperative intravenous analgesic will be administered in any child . thereafter the patient will be turned into the left lateral position and caudal blockade will be achieved under sterile conditions using a 22 gauge short beveled needle . bupivacaine 0.25 at the volume of 0.5 ml/kg and midazolam 50ug\kg will be administered 23 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
asa 1 age 2 to 6 years elective lower abdominal surgery bleeding disorder neurological or spinal disease allergy to local anesthetics Preschool Child: 2 Year-5 Year 2 Year(s) 6 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 01/10/2020 medical research ethics committee institutional review board
Ethics Committee Address
Street address City Postal code Country
l Gomhouria St, Dakahlia Governorate Mansoura 35511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome prevention of emergence agitation upon arrival to post anesthesia care unit 15 minutes 30 and 1 hour after that
Secondary Outcome postoperative analgesia upon arrival to PACU 1hour and 2 hours post surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
mansoura university children hospital l Gomhouria St, Dakahlia Governorate mansoura Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Omar Mahmoud Sherbin el-tera street Sherbin Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor mansoura university El Gomhouria St, Dakahlia Governorate Masoura 35511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hosam Saber Hosamsaber@yahoo.com +201005785775 Mansoura dakahlia gov
City Postal code Country Position/Affiliation
Mansoura Egypt lecturer of Anesthesia and icu Mansoura university
Role Name Email Phone Street address
Public Enquiries Mohamed Medany elmedany12@gmail.com +966568204698 Riyadh
City Postal code Country Position/Affiliation
Riyadh Saudi Arabia anesthesia specialist
Role Name Email Phone Street address
Scientific Enquiries omar reda omarreda49gooner@gmail.com +201091094554 sherbin
City Postal code Country Position/Affiliation
sherbin Egypt anesthesia resident
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this study may be provided to qualified researchers with academic interest in pediatric anesthesia . Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Clinical Study Report,Study Protocol 1 year controlled access will be granted for documents of this trial a third party will decide who can get access to the documents depending on quality of request
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