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.: PACTR202302563630917 Date of Approval: 08/02/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect Meperidine on Agitation and Pain following Sevoflurane Anesthesia in Children
Official scientific title Effects of Single Intraoperative Dose of Meperidine on Agitation and Pain following Sevoflurane Anesthesia in Children undergoing Hypospadias Surgery
Brief summary describing the background and objectives of the trial Emergence agitation (EA) is a frequent phenomenon especially in children recovering from sevoflurane-based general anesthesia. Its incidence is as high as 80%. It characterized by excitement, restlessness, disorientation, and other unusual behaviors, such as crying, shouting, kicking, disorientation and non-cooperation. It may lead to higher complication rates; increased bleeding from operative sites, pulling out a surgical drain or intravenous (iv) catheter, or surgical dressings, increase the risks of self-injury, unhappy parents, disturbances to the other recovering patients and prolonged PACU stay, in addition to maladaptive behavioral changes which can create another challenge to the postanesthetic care providers. Numerous medications have been suggested for either prophylaxis or treatment of EA with varying degrees of success; including ketamine, propofol, clonidine, midazolam, dexmedetomidine and opioids. However, some medications may show undesirable side effects or varying success. Among them, Meperidine, is a potent synthetic opioid analgesic agent with mu-opioid receptor agonist activity. The aim of the study is to evaluate the efficacy and the safety of intraoperative Meperidine used intravenously on the postoperative agitation and pain in pediatric patients recovering from sevoflurane anesthesia undergoing elective hypospadias surgery.
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 22/08/2022
Actual trial start date 26/09/2022
Anticipated date of last follow up 10/01/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
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 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 Meperidine group a single post-induction IV dose of 0.75mg/kg Meperidine. Bolus single IV dose. It will be given slowly over 50 seconds. It will be diluted in 10 ml saline as 5mg/ml and will be given slowly over 50 seconds 25
Control Group Saline group single post-induction IV equivalent volume from 10 ml normal saline (NS). Bolus, post-induction IV will be given slowly over 50 seconds 10 ml normal saline (NS) over 50 seconds 25 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
2-12 years old of either sex, ASA physical status I or II, scheduled for elective hypospadias surgery any known history of allergy to study drugs, active or severe renal, hepatic, neuromuscular, neurological, pulmonary or cardiac disorder, congenital heart or endocrine disease, consumers of anticonvulsive drugs, sedatives or antihistamines, emergency surgery, confirmed moderate to severe obstructive sleep apnea (OSA) disorder, major life changes one month before the operation, such as divorce of parents, death of parents, moving to a new home, changing to a new kindergarten. 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 26/09/2022 Institutional Review Board.. Medical Research Ethics Committee.
Ethics Committee Address
Street address City Postal code Country
Gomhoria street Mansoura 35511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome incidence of postoperative agitation in pediatrics using Pediatric Anesthesia Emergence Delirium (PAED) scores In PACU at 0, 5, 10, 15 minutes and then every 15 minutes until 2 hours
Secondary Outcome Pain Scores using FLACC pain rating scale (Face, Leg, Activity, Cry, Consolability) intraoperative hemodynamics, the duration of anesthesia, total duration of PACU stay, time to first postoperative rescue analgesic received, incidence of PONV, respiratory depression or any side effect, extubation time FLACC In PACU at 0, 5, 10, 15 minutes and then every 15 minutes until 2 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura University Children Hospital Gomhoria street Mansoura 35511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Tarek Habeeb Ramadan Gomhoria street Mansoura 35511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura University Al Gumhoria Mansoura 35511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Aly Eloraby Al Gomhuria Mansoura 35511 Egypt
Hosam Ibrahim Elsaid Saber Al Gomhuria Mansoura 35511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tarek Ramadan dr_tarekhabeeb@yahoo.com +01005663554 Al Gomhuria
City Postal code Country Position/Affiliation
Mansoura 35511 Egypt Lecturer of Anesthesia and Surgical ICU. Faculty of Medicine. Mansoura University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Eloraby orabyrsf@yahoo.com +201005170851 Al Gomhuria
City Postal code Country Position/Affiliation
Mansoura 35511 Egypt Lecturer of Anesthesia and Surgical ICU. Faculty of Medicine. Mansoura University
Role Name Email Phone Street address
Public Enquiries Hosam Saber hosamsaber@yahoo.com +201005785775 Al Gomhuria
City Postal code Country Position/Affiliation
Mansoura 35511 Egypt Assistant Professorof Anesthesia and Surgical ICU. Faculty of Medicine. Mansoura University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Study Protocol from 6 month up to 48 months after article publication Researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to dr_tarekhabeeb@yahoo.com. To gain access, data requestors will need to sign a data access agreement from the principle investigators.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
www.mans.edu.eg 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