Health Condition 1: null- For relieving post operative pain
Conditions
Interventions
Intervention1: Rectal Solution with applicator(Diclofenac sodium 50mg/squirt): two squirts(solution) of (Diclofenac sodium 50mg/squirt)
Control Intervention1: JONAC SUPPOSITORY (DICLOFENAC SODIUM 100
Sponsors
Lincoln Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.patients undergoing elective day open surgery i.e. Hernia or Standard Appendectomy 2.Patients undergoing surgical operation with SPINAL anesthesia 3.Patients who have signed and dated their written informed consent prior to initiation of study.
Exclusion criteria
Exclusion criteria: 1.Patients with psychiatric or mental diseases, or unable to follow the requests of the protocol including comprehension of VAS procedure 2.Known or suspected hypersensitivity to Diclofenac sodium or tramadol 3.Patient with any condition which in the opinion of the investigator makes the patients unsuitable for inclusion 4.Patients with a history of malignancy, epilepsy, hematological disorders, hepatic or renal insufficiency, peptic ulcer or active GI bleeding, chronic pain, long-term steroid therapy or continuous usage of analgesic drugs, relevant drug allergies or asthma, uncontrolled hypertension, neurologic or psychological disorders, alcohol abuse, opium addict or using any drug that modifies pain perception and inability to tolerate rectal sodium diclofenac are excluded from the study 5.Patients with active or history of recurrent rectal bleeding or hemorrhage. 6.Patients with any inflammatory lesions of rectum or anus 7.Patients with hypervolemia or dehydration from any cause 8.Patients with Severe heart failure 9.Patients with history of haemorrhagic diathesis or confirmed or suspected cerebrovascular bleeding 10.Patients with prolonged operations associated with a risk of haemorrhage 11.The outpatients will be excluded from the study 12.Patients without the ability to comply with the study protocol and complete the study in the judgment of the investigator 13.Pregnant or breast feeding women 14.Females of child bearing potential, not taking adequate contraception 15.Any condition or situation which, in the opinion of the investigator, might pose a risk to the subject or interfere with participation in the study like history of bronchial asthma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative pain assessment with VAS(Visual Analogue Scale)score ranges from 0 to 10Timepoint: Postoperative pain assessment all patients will undergo efficacy measurement over VAS(Visual Analogue Scale)range 0-10 at 0.5,1,1.5,2,6,12 and 24 hours after dosing | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety outcome will be measured as spontaneously reported and directly observed Adverse Events(AEs)after administered dose until post treatment follow upTimepoint: Safety of patients will be evaluated by vital signs (temperature, blood pressure, Pulse rate and respiratory rate) and monitoring adverse events during study period at 0.5,1,1.5,2,6,12 and 24 hours | — |
Countries
India
Contacts
Public ContactMr Kapil Pandya
Synergist Therapeutic Pvt Ltd
Outcome results
None listed