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.: PACTR201711002741378 Date of Approval: 02/11/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title analgesic role of premative Oral Melatonin before thoracic epidural in bilateral multiple fracture ribs
Official scientific title Role of addition of Oral Melatonin in thoracic epidural analgesia in pain control for patients with bilateral multiple fracture ribs
Brief summary describing the background and objectives of the trial Multiple fractured ribs (MFRs) cause severe pain, which may be more debilitating and harmful than the injury itself. Pain limits one¿s ability to cough and breathe deeply, resulting in sputum retention, atelectasis, and a reduction in functional residual capacity (FRC). These factors in turn result in decreased lung compliance, ventilation- perfusion mismatch, hypoxemia, and respiratory distress. Melatonin possesses sedative, hypnotic, analgesic, anti-inflammatory, ant oxidative, and chronobiotic properties that distinguish it as an attractive alternative premedicant. Many strategies have been described to reduce such pain. These have included parenteral opiates, non-steroidal anti-inflammatory drugs (NSAIDs), epidural and paravertebral infusions of local anesthetics, intercostal and phrenic nerve blockades, and cryotherapy. Melatonin has been tried during surgical operating conditions and has been shown to enhance both preoperative and post-operative analgesia
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning,pain in patients with bilateral multiple fracture ribs
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 04/11/2017
Actual trial start date
Anticipated date of last follow up 03/11/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants)
Recruitment status Not yet 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 randomisation table from a statistics book Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Placebo group one placebo tablets about 1 hr before epidural infusion of local anesthetics every 12 hours till cessatin of bupavcaine inusion In this group, patients will be received oral placebo tablets (every 12 hours) immediately after arrival of hospital and about 1 hr before thoracic epidural infusion of local anesthetics 40 Placebo
Experimental Group melatonin group one melatonin tablets 5mg about 1 hr before epidural infusion of local anesthetics every 12 hours till cessatin of bupavcaine inusion In this group, patients will be received oral melatonin tablets (5mg every 12 hours) immediately after arrival of hospital and about 1 hr before before thoracic epidural infusion of local anesthetics 40 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
80 ASA Physical status I &II, 18-50 years presented with bilateral fracture ribs. ¿ Schizophrenia or other psychotic disorder or cognitive impairment ¿ History of drug dependency or substance addiction ¿ A known sensitivity to melatonin or pregabalin, ¿ known to be allergic to any medicines ¿ History of drug or alcohol abuse, taking opioids or sedative medications, and had a history of psychiatric conditions. ¿ Patients with a history of taking pregabalin or gabapentin ¿ pathological rib fractures, kyphoscoliosis ¿ BMI <18.5 or >30 kg m2 ¿ history of cerebro-vascular disease, seizure disorders, central nervous system diseases ¿ coagulation disorders ¿ local skin infection at the side of injection 18 Year(s) 50 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 25/10/2017 ¿ research ethics committee, quality assurance unit¿ research ethics committee, quality assurance unit
Ethics Committee Address
Street address City Postal code Country
1, algeish st, tanta,algharbia governate, egypt tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the time for the first request for rescue analgesia from 30 min after infusion till 24 hrs after cessation of infusion
Secondary Outcome the severity of pain from 30 min after infusion till 24 hrs after cessation of infusion
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
tana university hospital 1, algeish st, tanta,algharbia governate, egypt tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
tana university hospital 1, algeish st, tanta,algharbia governate, egypt tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor tana university hospital 1, algeish st, tanta,algharbia governate, egypt tanta 31527 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed Mohammed Fetouh Abdelhamed el gendy mosque st ,tanta,algharbia governate, egypt tanta 31511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator amany Omara amanyfaheem2011@yahoo.com 01008372249 el estad st, algharbia governate, egypt
City Postal code Country Position/Affiliation
tana 31511 Egypt
Role Name Email Phone Street address
Public Enquiries nada Omara Dr.nada.emera@gmail.com 01118342012 12 nor l din st, tanta,algharbia governate, egypt
City Postal code Country Position/Affiliation
tana 31511 Egypt
Role Name Email Phone Street address
Scientific Enquiries sohair soliman sohairsoliman@hotmail.com 01155338808 moheb street, Tanta, Egypt
City Postal code Country Position/Affiliation
tana 31511 Egypt
REPORTING
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