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.: PACTR201505001139269 Date of Approval: 10/05/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Pre-emptive paracetamol versus fentanyl on postadenotonsilectomy pain
Official scientific title Pre-emptive paracetamol infusion versus fentanyl effects on postadenotonsilectomy pain in OSA patients.
Brief summary describing the background and objectives of the trial OSA is common of all age in children, but mostly occurs between 2- 8 years age group, and its prevalence is equally between boys and girls. Hypertrophy of adenotonsillar tissue is the main factor in development of OSA during sleep in children. So, adenotonsillectomy is the main treatment for children OSA. Posttonsilectomy pain, there is little published evidence to recommend a specific analgesic technique for T&A in the child with OSAS. Opioid, increased respiratory sensitivity, to respiratory depression during recovery period, including hypoxia.due to this potential respiratory problems , all children with history of OSA should receive an analgesic drugs that minimize these problems and pain control, postoperativelly. Paracetamol infusion is an alternative non opioid drug to relieve postoperative pain, its safety and pharmacokinetic properties have been established for children as young as 1 yr of age. The present study was designed as randomized controlled trial to evaluate paracetamol as a preemptive analgesia in OSA undergoing adenotonsillectomy in compare with fentanyl as established analgesic (primary goal), detecting adverse events (secondary goal).
Type of trial RCT
Acronym (If the trial has an acronym then please provide) OSA
Disease(s) or condition(s) being studied Obstructive Sleep Apnae, adenotonsillectomy,Oral Health,Respiratory,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 20/05/2015
Actual trial start date
Anticipated date of last follow up 20/11/2015
Actual Last follow-up date
Anticipated target sample size (number of participants) 108
Actual target sample size (number of participants) 120
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
Research Ethics Committee, Tanta University, Facualty of Medicine Approval code: 2948/12/14
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Patients will be randomly table allocated into two equal groups; group P (Paracetamol infusion group), group F (Fentanyl group) by using sealed opaque envelope technique; the envelope will be open by another investigator who has no subsequent role in the study. sealed opaque envelope technique 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 paracetamol infusion 15 mg/kg preemptive paracetamol infusion 15 mg/kg once IV line will be fixed 60
Control Group fentanyl 1 uq/kg i.v. preemptive fentanyl 1 uq/kg i.v. bolus as soon as IV line will be fixed 60 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age 2-10 years, ASA I-II, of both sexes with OSA undergoing elective day case adenoidectomy with or without tonsillectomy, All patients have OSA on the basis of clinical symptoms, such as sever snoring, restlessness sleep, daytime somnolence, failure to thrive. known sensitivity to the drugs under study, developmental delay, neurological or neuromuscular disorders, hepato-renal insufficiency. Craniofacial abnormalities use of psychotherapeutic medications. 2 Year(s) 10 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 Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
El-Geish st Tanta 31257 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Paracetamol as preemptive analgesia compared with fentanyl as established analgesic. 1) HR, MABP, Spo2, ETCo2 every 5 min during anesthesia 2) Time to awakening; Time extubation 3) Objective Pain Score PACU on arrival and 5, 15 min then every 15 min for 2 hrs 4) EmergenceAgitation by Pediateric Anesth Emergence Delirium scale and 5-point agitation scale 5) HR, MAB, RR, Spo2 recorded in PACU every 5 min first 15 min then every 15 min for 2 hrs. 6) Time patient stay in PACU
Secondary Outcome Detecting adverse events Any adverse side effects as nausea and vomiting, episode of desaturation with decrease Spo2 below 95% will be recorded
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospital, Facualty of Medicine El-Geish st, Tanta / Gharbia 31257 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
The researchers supported this work fund. Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Rehab Said ELKalla El-Geish st, Tanta / Gharbia 31257 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Taysser Mahmoud Abd ELRaheem El-Geish st, Tanta / Gharbia 31257 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rehab ElKalla rehouba10@hotmail.com +201285700765 El-Geish st
City Postal code Country Position/Affiliation
Tanta/ Gharbia 31257 Egypt Lecturer of Anesthesiology and Surgical Intensive Care
Role Name Email Phone Street address
Public Enquiries Taysser Abd ELRaheem taysser.mahmoud@yahoo.com +20403418334 El-Geish st
City Postal code Country Position/Affiliation
Tanta/ Gharbia 31257 Egypt Lecturer of Anesthesiology and Surgical Intensive Care
Role Name Email Phone Street address
Scientific Enquiries Rehab ElKalla rehouba10@hotmail.com +201285700765 El-Geish st
City Postal code Country Position/Affiliation
Tanta/Gharbia 31257 Egypt lecturer of Anesthesia and Surgical Intensive Care, Faculty of Medicine, Tanta University
REPORTING
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