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.: PACTR201604001351168 Date of Approval: 18/11/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy of pre-incisional peritonsillar infilteration of ketamine vs magnesium for post-tonsillectomy analgesia in children
Official scientific title Efficacy of pre-incisional peritonsillar infilteration of ketamine vs magnesium for post-tonsillectomy analgesia in children
Brief summary describing the background and objectives of the trial Tonsillectomy is a common and painful procedure in children. Post-tonsillectomy problems include pain, hemorrhage, laryngospasm and airway obstruction (1) Treatment of this type of pain is a difficult task and could remain for 4 days after the surgery that results in decreased oral intake, prolonged hospital stay, and a delay in return to the normal activities (2). Many treatment modalities for Post tonsillectomy pain have been used(3). Because of the absence of any respiratory depressant effect, nausea, vomiting and bleeding problems there has been a renewed interest in local anaesthetic techniques in children as an effective means of postoperative pain control(4). During the past few years, after the discovery of the role of N-methyl-D-aspartate (NMDA) receptor on pathophysiology of postoperative pain, local and systemic use of NMDA receptor antagonists such as ketamine and magnesium has increased, Studies indicate that these receptors interact in the periphery(5,6) and their antagonists reduce chronic pain(7). Magnesium is a calcium and NMDA receptor antagonist which can adjust pain and act as an opioid sparing especially if used in higher pain scores or with a larger dose(8) Because ketamine is an NMDA receptor antagonist, it is hypothesized to prevent or reverse central sensitization and consequently reduce postoperative pain. The local anaesthetic effects are likely from the blocking action of ketamine on sodium channel(9,10). Patients and Methods This prospective randomized double blinded study will be done in the department of Anesthesiology, faculty of medicine, Beni-Suef University, after obtaining approval from the ethical committee of the Institution and obtaining consent from legal guardian of all children involved in the study and informed ascent from the child when applicable.
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 12/11/2015
Actual trial start date 12/11/2015
Anticipated date of last follow up 16/05/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 102
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 randomization table created by a computer software program 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 ketamine 0.5mg/kg 1 year observation 51 Active-Treatment of Control Group
Experimental Group magnesium 10mg/kg peritonsillalar infilteration 51
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Children aging 8-12 years. - ASA physical status ¿ and ¿¿. - inability or refusal to consent. - obstructive sleep apnea syndrome. - coagulation disturbances. - systemic , endocrine or cardiovascular disease. - allergy to the study drug. - peritonsillar abscess. - neurological or psychiatric disorders. - renal impairment. 8 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 10/11/2015 FM-BSU REC
Ethics Committee Address
Street address City Postal code Country
bni suif bni suif Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain at 0 (on arrival at PACU), 30, 60, and 90 min postoperative. They were also recorded at 2, 4,8 and 12 h
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of medicine bni suif bni suif Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
bni suif university bni suif bni suif Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor mohamed a. mahran mohmed mtwly giza Egypt University
COLLABORATORS
Name Street address City Postal code Country
hany yasin hadayk ahram giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohamed mahran mali7511@yahoo.com 01006945585 mohamed mtwly
City Postal code Country Position/Affiliation
giza Egypt lecturer of anesthesia
Role Name Email Phone Street address
Public Enquiries hazem abdel wahab hazemwahab@yahoo.com 010063003694 61b bnisuif
City Postal code Country Position/Affiliation
bnisuif Egypt
Role Name Email Phone Street address
Scientific Enquiries hazem abdel wahab hazemwahab@yahoo.com 010063003694 61b bnisuif
City Postal code Country Position/Affiliation
bnisuif Egypt
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