Comparative Study Between the Effect of Diclofanic and Ketorolac in Post Tonsillectomy Pain Management
Primary Purpose
Pain, Acute
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
diclofenac
ketorolac
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Acute focused on measuring tonsillectomy, post operative analgesia, diklofanic, ketorolac
Eligibility Criteria
Inclusion Criteria:
- Children scheduled for elective tonsillectomy\adenotnsillectomy for chronic or recurrent tonsillitis and aged between 6 to 12 years
Exclusion Criteria:
- Known hypersensitivity to medication drugs.
- Coagulation disorders, thrombocytopenia or active bleeding for any cause.
- Bronchial asthma.
- Significant cardiac, renal, pulmonary, hepatic disease or peptic ulcer.
- The use of any analgesic medications within 24h preoperative or antiplatelet medication within the past 2 weeks.
Sites / Locations
- Assiut university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
diclofenac
ketorolac
Arm Description
patients will receive intra-operative diclofenac sodium at dose of 0.3 mg/kg intravenously then will continue postoperatively on the same drug received intra-operative.
patients will receive intra-operative ketorolac tromethamine at dose of 0.5 mg/kg intravenously then will continue postoperatively on the same drug received intra-operative.
Outcomes
Primary Outcome Measures
pain relieve
the verbal rating scale (VRS; 0 = no pain, 1 = mild pain, 2 = moderate pain, 3= severe pain, and lastly 4= excruciating pain). VRS assessment will be performed immediately postoperative and 3, 6, 12 and 24h postoperatively
Secondary Outcome Measures
bleeding
Bleeding score will be assessed by the surgeon at the end of the operation using the following Scale for bleeding assessment (0 = no bleeding, 1 = bleeding as usual, 2 = bleeding more than usual, 3 = profuse, 4 = excessive, and lastly 5 = excessive and continuous).
dysphagia
time needed to restore normal dietary habbit
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03178539
Brief Title
Comparative Study Between the Effect of Diclofanic and Ketorolac in Post Tonsillectomy Pain Management
Official Title
Comparative Study Between the Effect of Diclofanic and Ketorolac in Post Tonsillectomy Pain Management
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 31, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Compare between the analgesic efficacy of diclofenac sodium and ketorolac tromethamine in post-tonsillectomy pain management.and Compare between the effect of diclofenac sodium and ketorolac tromethamine on post-tonsillectomy bleeding
Detailed Description
patients will be randomly allocated to two groups of 50 patients each Group (A): will receive intra-operative diclofenac sodium at dose of 0.3 mg/kg intravenously.
Group (B): will receive intra-operative ketorolac tromethamine at dose of 0.5 mg/kg intravenously.
Then the two groups will continue postoperatively on the same drug received intra-operative
I. Intra-operative data:
Bleeding score will be assessed by the surgeon at the end of the operation using the following Scale for bleeding assessment (0 = no bleeding, 1 = bleeding as usual, 2 = bleeding more than usual, 3 = profuse, 4 = excessive, and lastly 5 = excessive and continuous).
II. Early Post-operative data:
Post- tonsillectomy bleeding assessments;
Bleeding score will be recorded immediately postoperative and 3, 6, 12 and 24h postoperatively.
Hospital re-admission because of bleeding.
Re-operation because of bleeding.
Post- tonsillectomy pain assessments; Pain intensity will be assessed postoperatively by the verbal rating scale (VRS; 0 = no pain, 1 = mild pain, 2 = moderate pain, 3= severe pain, and lastly 4= excruciating pain). VRS assessment will be performed immediately postoperative and 3, 6, 12 and 24h postoperatively. Analgesia will be given if requested or if the VRS≥3. Patients in Group A will receive diclofenac sodium 0.3 mg/kg iv, while patients in Group B will receive ketorolac tromethamine 0.5 mg/kg.
The total consumption of analgesics used in each group in the first 24 h postoperative will be calculated and the time of the first request for analgesia will be recorded.
- Time needed to restore normal dietary habits.
IV. Late Post-operative data:
As aweekly follow up for 2 weeks :
bleeding tendency
Dysphagia.
Time needed to restore normal dietary habits
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute
Keywords
tonsillectomy, post operative analgesia, diklofanic, ketorolac
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
diclofenac
Arm Type
Active Comparator
Arm Description
patients will receive intra-operative diclofenac sodium at dose of 0.3 mg/kg intravenously then will continue postoperatively on the same drug received intra-operative.
Arm Title
ketorolac
Arm Type
Active Comparator
Arm Description
patients will receive intra-operative ketorolac tromethamine at dose of 0.5 mg/kg intravenously then will continue postoperatively on the same drug received intra-operative.
Intervention Type
Drug
Intervention Name(s)
diclofenac
Other Intervention Name(s)
Voltaren
Intervention Description
non steroidal anti-inflammatory drug
Intervention Type
Drug
Intervention Name(s)
ketorolac
Other Intervention Name(s)
Tromethamine
Intervention Description
non steroidal anti-inflammatory drug
Primary Outcome Measure Information:
Title
pain relieve
Description
the verbal rating scale (VRS; 0 = no pain, 1 = mild pain, 2 = moderate pain, 3= severe pain, and lastly 4= excruciating pain). VRS assessment will be performed immediately postoperative and 3, 6, 12 and 24h postoperatively
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
bleeding
Description
Bleeding score will be assessed by the surgeon at the end of the operation using the following Scale for bleeding assessment (0 = no bleeding, 1 = bleeding as usual, 2 = bleeding more than usual, 3 = profuse, 4 = excessive, and lastly 5 = excessive and continuous).
Time Frame
two weeks
Title
dysphagia
Description
time needed to restore normal dietary habbit
Time Frame
two weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children scheduled for elective tonsillectomy\adenotnsillectomy for chronic or recurrent tonsillitis and aged between 6 to 12 years
Exclusion Criteria:
Known hypersensitivity to medication drugs.
Coagulation disorders, thrombocytopenia or active bleeding for any cause.
Bronchial asthma.
Significant cardiac, renal, pulmonary, hepatic disease or peptic ulcer.
The use of any analgesic medications within 24h preoperative or antiplatelet medication within the past 2 weeks.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hala S Abdel_Ghaffar, MD
Organizational Affiliation
Assistant professor, faculty of medicine, Assiut university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut university hospital
City
Assiut
State/Province
Asyut Governorate
ZIP/Postal Code
715715
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparative Study Between the Effect of Diclofanic and Ketorolac in Post Tonsillectomy Pain Management
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