IbuprofenNCT05782608
IV Ibuprofen vs Ketorolac in Post Operative Pain in Colorectal Cancer Surgeries in Obese Patient
A study testing IV ibuprofen and IV ketorolac in people with Ibuprofen and Ketorolac, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to assess the Efficacy of IV Ibuprofen and Ketorolac in the Management of Postoperative Pain in obese patients Following abdominal cancer surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ibuprofen, Ketorolac, Colorectal Cancer
- What is being tested?
- IV ibuprofen and IV ketorolac
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 15 Nov 2023
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA class II.
- Age ≥ 18 and ≤ 65 Years.
- Patients undergoing midline abdominal incision for colorectal cancer surgery.
- Body mass index (BMI) >30 kg/m2.
Who cannot join
- Renal and hepatic insufficiency.
- Unstable cardiovascular disease.
- History of psychiatric and cognitive disorders.
- Patients allergic to medication used.
- Asthmatic patients.
- Peptic ulcer patients.
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- patients on regular opioid consumption.
- History of allergy or hypersensitivity to any component of ibuprofen, other NSAIDs, opioids or COX- 2 inhibitors.
- Subjects with active significant anemia, history of asthma .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of IV Ibuprofen vs Ketorolac in Controlling Post Operative Pain in Colorectal Cancer Surgeries in Obese Patient: A Randomized Double Blinded Controlled Study
The aim of this study is to assess the Efficacy of IV Ibuprofen and Ketorolac in the Management of Postoperative Pain in obese patients Following abdominal cancer surgery.
Read the detailed description
Colorectal cancer is the third most common cancer in the world, after lung and breast cancer, and the 4th most reported cause of cancer death, reporting about 8.0 % of all cancer deaths According to the WHO, Egypt was ranked the 18th regarding the prevalence of obesity, and Deaths attributable to non-communicable diseases represent about 71% of the total mortality burden.Data obtained from the past 25 years suggest that the obesity is a cause of nearly 14% of cancer deaths in men and up to 20% of cancer deaths in women. Most of cases experience moderate to severe pain after colorectal surgery, So effective and individualized analgesia required after colorectal surgery, as pain response to surgery is not predicted.
Opioids are an effective analgesic for moderate to severe pain, although their efficacy is limited by adverse effects including respiratory depression, failure to reduce pain caused by tissue inflammation, nausea, emesis, drowsiness, moderate sedation, pruritus, urinary retention and ileus.
Regional anesthesia can be an alternative to opioids but according to multiple studies it was associated with technical difficulties and higher failure rates in obese patients. Ibuprofen is a nonselective inhibitor of cyclooxygenases (COX) enzymes, the inhibition ratio of COX-1 to COX 2 of Ibuprofen is 2,5:1 that has a low risk of bleeding or gastrointestinal problems, while other NSAID as for example ketorolac have an inhibition ratio of 330:1 for COX-1 to COX-2 , reason for a high risk of side effects , therefore its use is controversial in most of perioperative settings. ketorolac 10 and 20 mg and ibuprofen 400 mg have the same analgesic effect that was significant by hour 1 and persisted for 5-6 hours for each active medication.
- Conditions
- Ibuprofen, Ketorolac, Colorectal Cancer
- Being tested
- IV ibuprofen, IV ketorolac
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV ibuprofenDrug
Group 1 will receive IV ibuprofen 400mg \ 6 hours the first dose will be administrated immediately post operative.
IV ketorolacDrug
Group 2 will receive 20 mg IV ketorolac\ 6 hours the first dose will be administrated immediately post operative
| Study group | Role | What they receive |
|---|---|---|
| group (I) | Active comparator | Not described Receives: Drug: IV ibuprofen |
| group (II) | Active comparator | Not described Receives: Drug: IV ketorolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Pain
Pain using visual analogue score (VAS score), Using a ruler to measure the distance in centimetres from the 'no pain marker' (or zero) to the current pain mark. This provides a pain intensity score out of 10; for example, 6 out of 10 (or 6/10).
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start1 Apr 2023
- Primary completion15 Nov 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IbuprofenStudies of the same condition, open and under way.
- More trials run by Cairo 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mahmoud Ismail Salama, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782608
- Sponsor's protocol ID
- MS-503-2022
- Status last verified
- Jan 2024
- First submitted
- 11 Mar 2023
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon reasonable request from the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of IV Ibuprofen vs Ketorolac in Controlling Post Operative Pain in Colorectal Cancer Surgeries in Obese Patient: A Randomized Double Blinded Controlled Study
- ClinicalTrials.gov ID
- NCT05782608
- Acronym / sponsor ID
- MS-503-2022
- Conditions
- Ibuprofen, Ketorolac, Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 23 Mar 2023 (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.
The aim of this study is to assess the Efficacy of IV Ibuprofen and Ketorolac in the Management of Postoperative Pain in obese patients Following abdominal cancer surgery.
Detailed description
Colorectal cancer is the third most common cancer in the world, after lung and breast cancer, and the 4th most reported cause of cancer death, reporting about 8.0 % of all cancer deaths According to the WHO, Egypt was ranked the 18th regarding the prevalence of obesity, and Deaths attributable to non-communicable diseases represent about 71% of the total mortality burden.Data obtained from the past 25 years suggest that the obesity is a cause of nearly 14% of cancer deaths in men and up to 20% of cancer deaths in women. Most of cases experience moderate to severe pain after colorectal surgery, So effective and individualized analgesia required after colorectal surgery, as pain response to surgery is not predicted.
Opioids are an effective analgesic for moderate to severe pain, although their efficacy is limited by adverse effects including respiratory depression, failure to reduce pain caused by tissue inflammation, nausea, emesis, drowsiness, moderate sedation, pruritus, urinary retention and ileus.
Regional anesthesia can be an alternative to opioids but according to multiple studies it was associated with technical difficulties and higher failure rates in obese patients. Ibuprofen is a nonselective inhibitor of cyclooxygenases (COX) enzymes, the inhibition ratio of COX-1 to COX 2 of Ibuprofen is 2,5:1 that has a low risk of bleeding or gastrointestinal problems, while other NSAID as for example ketorolac have an inhibition ratio of 330:1 for COX-1 to COX-2 , reason for a high risk of side effects , therefore its use is controversial in most of perioperative settings. ketorolac 10 and 20 mg and ibuprofen 400 mg have the same analgesic effect that was significant by hour 1 and persisted for 5-6 hours for each active medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group (I) | Active comparator | Drug: IV ibuprofen |
| group (II) | Active comparator | Drug: IV ketorolac |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA class II.
- Age ≥ 18 and ≤ 65 Years.
- Patients undergoing midline abdominal incision for colorectal cancer surgery.
- Body mass index (BMI) >30 kg/m2.
Key exclusion criteria (9 listed)
- Renal and hepatic insufficiency.
- Unstable cardiovascular disease.
- History of psychiatric and cognitive disorders.
- Patients allergic to medication used.
- Asthmatic patients.
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 |
|---|---|---|
| IV ibuprofenGroup 1 will receive IV ibuprofen 400mg \ 6 hours the first dose will be administrated immediately post operative. | Drug | group (I) |
| IV ketorolacGroup 2 will receive 20 mg IV ketorolac\ 6 hours the first dose will be administrated immediately post operative | Drug | group (II) |
Primary outcome
Assessment of Pain
Time frame: During procedure
Pain using visual analogue score (VAS score), Using a ruler to measure the distance in centimetres from the 'no pain marker' (or zero) to the current pain mark. This provides a pain intensity score out of 10; for example, 6 out of 10 (or 6/10).
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 19 Jan 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon reasonable request from the principal investigator
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IV ibuprofen and IV ketorolac in people with Ibuprofen and Ketorolac, run by Cairo 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 4 inclusion and 9 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 19 Jan 2024. 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.
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?
Assessment of Pain (time frame: During procedure). 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 19 Jan 2024.