Add-on therapy in the preemptive analgesia (pre-medication) in patients undergoing laparascopy cholecistectomy. MedDRA version: 9.1 Level: SOC Classification code 10042613
Conditions
Interventions
Trade Name: Oramorph 20 mg/ml Losung
Pharmaceutical Form: Oral drops, solution
Other descriptive name: Morphine sulphate
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Con
Sponsors
MOLTENI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent obtained, 2.Patients of either sex aged >=18 and = 65 years; 3.Patients candidate to surgical intervention of laparascopy cholecistectomy; 4.Patients in class I, II or III physical status of the classification system of American Society of Anesthesiologists (ASA); 5.Absence or mild pre-operative pain (i.e. a NRS score between 0-3 included); 6.Female subjects of childbearing potential (i.e., not status post hysterectomy or tubal ligation) must be using an appropriate method of contraception (implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner). A negative pregnancy test on blood must be obtained at the screening visit, if applicable; 7.Patient’s co-operative attitude and able to understand and adhere to study protocol procedures and timelines Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Patients in class IV-VI of the ASA; 2.Any use of opioid analgesic drugs; 3.Use of opioids or other analgesic drugs in the 12 hours preceding the programmed surgical intervention; 4.Patients with renal (serum creatinine = 1.4 mg/dL), or hepatic failure, or diabetes mellitus which represent a risk to the subjects; 5.Severe cognitive impairment, or mental deterioration, or major psychiatric diseases, as confirmed by a baseline Mini-mental state examination (MMSE) score < 24; 6.Known or suspected intolerance, or contraindications in the use of study medications and/or study medications’ formulation ingredients; 7.History of alcoholism, drug abuse, psychological or other emotional problems that could invalidate informed consent or limit the subject compliance with protocol requirements; 8.Breastfeeding females; 9.Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study; 10.Patients who received any investigational drug within the last 12 weeks; 11.Employees of the investigator or study centre (i.e., principal investigator, sub-investigator, study coordinators, other study staff, employees, or contractors of each), with direct involvement in the proposed study or other studies under the direction of that investigator and/or study centre, as well as family members of the employees or the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to assess the efficacy of morphine sulphate oral solution (Oramorph) 30 mg given as add-on therapy in the preemptive analgesia (pre-medication) in patients undergoing laparascopy cholecistectomy.;Secondary Objective: • To assess the economic impact of morphine sulphate oral solution in reducing the use of analgesics (mainly opioids in PCA) and in reducing the post anesthesia care unit (PACU) discharge time; • To assess the sedative effects of the investigational medicinal product (IMP); • To assess the local tolerability and general safety of the IMP.;Primary end point(s): The primary efficacy variable of the study is the mean change from baseline in pain score at rest measured in the first 3 hours following the end of anaesthesia by means of the NRS (0-10 score). | — |
Countries
Italy
Outcome results
None listed