Pain, AcutePhase 2/3NCT03178539
Comparative Study Between the Effect of Diclofanic and Ketorolac in Post Tonsillectomy Pain Management
A Phase 2/3 study testing diclofenac and ketorolac in people with Pain, Acute, run by Assiut University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Pain, Acute
- What is being tested?
- diclofenac and ketorolac
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 31 Jan 2017to 31 Dec 2018
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children scheduled for elective tonsillectomy\adenotnsillectomy for chronic or recurrent tonsillitis and aged between 6 to 12 years
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
- 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
- Conditions
- Pain, Acute
- Being tested
- diclofenac, ketorolac
- Keywords
- tonsillectomy, post operative analgesia, diklofanic, ketorolac
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diclofenacDrug
Also called Voltaren
non steroidal anti-inflammatory drug
ketorolacDrug
Also called Tromethamine
non steroidal anti-inflammatory drug
| Study group | Role | What they receive |
|---|---|---|
| diclofenac | Active comparator | 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. Receives: Drug: diclofenac |
| ketorolac | Active comparator | 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. Receives: Drug: ketorolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours
Secondary outcomes (2)
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).
Measured: two weeks
dysphagia
time needed to restore normal dietary habbit
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start31 Jan 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hala Saad Abdel-Ghaffar, Assiut University
- Investigators
- Hala S Abdel_Ghaffar, MD, Principal investigator, Assistant professor, faculty of medicine, Assiut university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178539
- Sponsor's protocol ID
- 17100114
- Status last verified
- Jul 2020
- First submitted
- 5 Jun 2017
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between the Effect of Diclofanic and Ketorolac in Post Tonsillectomy Pain Management
- ClinicalTrials.gov ID
- NCT03178539
- Acronym / sponsor ID
- 17100114
- Conditions
- Pain, Acute
- Keywords
- tonsillectomy, post operative analgesia, diklofanic, ketorolac
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 31 Jan 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 7 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diclofenac | Active comparator | Drug: diclofenacpatients 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. |
| ketorolac | Active comparator | Drug: ketorolacpatients 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children scheduled for elective tonsillectomy\adenotnsillectomy for chronic or recurrent tonsillitis and aged between 6 to 12 years
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diclofenacAlso: Voltarennon steroidal anti-inflammatory drug | Drug | diclofenac |
| ketorolacAlso: Tromethaminenon steroidal anti-inflammatory drug | Drug | ketorolac |
Primary outcome
pain relieve
Time frame: 24 hours
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
2 secondary outcomes
bleeding
Time frame: two weeks
dysphagia
Time frame: two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hala S Abdel_Ghaffar, MD principal investigator
Assistant professor, faculty of medicine, Assiut university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing diclofenac and ketorolac in people with Pain, Acute, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain relieve (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.