Postoperative PainNCT05610384
Ibuprofen Versus Ketorolac for Perioperative Pain Control After Open Hysterectomy
A study testing Ketorolac Injectable Solution and Ibuprofen 800 mg in people with Postoperative Pain and Hysterectomy, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the analgesic effect of intravenous ibuprofen to ketorolac for pain control after open hysterectomy Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Postoperative Pain, Hysterectomy
- What is being tested?
- Ketorolac Injectable Solution and Ibuprofen 800 mg
- 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
- 20 Nov 2022to 16 May 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 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult (40-65 years)
- ASA I-II women
- scheduled to undergo open elective abdominal hysterectomy with or without salpingo-oophorectomy
Who cannot join
- renal impairment,
- allergy to any of study's drugs,
- history of gastrointestinal bleeding or ulceration, or inflammatory bowel disease,
- severe cardiac comorbidity (impaired contractility with ejection fraction < 50%, heart block, significant arrhythmias, tight valvular lesions),
- patients undergoing surgery for suspected gynaecological cancer,
- patients on chronic analgesic medication,
- inability to comprehend the Visual Analogue Pain Scoring Scale
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravenous Ibuprofen Versus Ketorolac for Perioperative Pain Control After Open Hysterectomy: a Randomized Controlled Trial
The aim of this study is to compare the analgesic effect of intravenous ibuprofen to ketorolac for pain control after open hysterectomy
Read the detailed description
Thirty minutes before the surgery, all patients will receive 1 gm paracetamol intravenously then every 6 hours postoperatively.
A research assistant is responsible for opening the envelopes, group assignment and drug preparation (the three doses will be prepared and marked with the patient's name as well as the time of administration) without any further involvement in the study. The patient, attending anesthetist, nurse and data collector will be blinded to the administered drug.
Upon arrival to the operating room, routine monitors (electrocardiogram, pulse oximetry, and non-invasive blood pressure monitor) will be applied; intravenous line will be secured, and prophylactic antiemetic will be provided in the form of slow intravenous injection of 8 mg dexamethasone drugs.
Anesthesia Anesthesia will be induced with 2 mg/kg propofol, 1 mcg/kg fentanyl, and tracheal intubation will be facilitated by 0.5 mg/kg atracurium after loss of consciousness. Anesthesia will be maintained with isoflurane 1-1.2% in oxygen and 0.1 mg/kg atracurium every 20 minutes. Intraoperative analgesia will be in the form of 1 mcg/kg fentanyl boluses as needed.
Postoperatively, pain assessments using the visual analogue scale (VAS) will be performed at rest and during movement (knee flexion) at 0.5, 2, 4, 6, 10, 18, and 24 h after leaving the operating room. If the VAS score is > 3 intravenous titration of 2 mg morphine given slowly to be repeated after 30 minutes if pain persisted.
Intravenous ondansetron 4 mg will be given to treat postoperative nausea or vomiting
- Conditions
- Postoperative Pain, Hysterectomy
- Being tested
- Ketorolac Injectable Solution, Ibuprofen 800 mg
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketorolac Injectable SolutionDrug
ketorolac 30 mg (diluted in 200 mL normal saline) intravenously over 5 minutes before induction of anesthesia then every 8 hours postoperatively
Ibuprofen 800 mgDrug
ibuprofen 800 mg intravenously (Diluted in 200 mL of normal saline) over 5 minutes before induction of anesthesia then every 8 hours postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Ketorolac group | Active comparator | ketorolac 30 mg Receives: Drug: Ketorolac Injectable Solution |
| Ibuprofen group | Active comparator | ibuprofen 800 mg Receives: Drug: Ibuprofen 800 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean dynamic VAS
average postoperative VAS
Measured: 24 hour after surgery
Secondary outcomes (6)
static VAS
a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')
Measured: 30 minutes, 2, 4, 6, 10, 18, 24 hours postoperatively
dynamic VAS
a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')
Measured: procedure (during knee flexion)
time to first analgesia requirement
hours
Measured: period from extubation until first analgesic requirement during the first 24 hour postoperatively
morphine consumption
mg
Measured: during the first 24 hour postoperatively
time to independent movement
time from extubation to be able independently mobile e.g. using the bathroom
Measured: during the first 24 hour postoperatively
patients satisfaction
on scale of 0 to 10
Measured: at the end of 24 hour postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start20 Nov 2022
- Primary completion15 May 2023
- Study completion16 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hasanin, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05610384
- Sponsor's protocol ID
- MD-246-2022
- Status last verified
- Jul 2023
- First submitted
- 3 Nov 2022
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data will be share upon reasonable request from the PI
Publications
Amin S, Hasanin A, Attia OA, Mostafa M, Elzayat NS, Elsherbiny M, Eissa AA. Intravenous ibuprofen versus ketorolac for perioperative pain control in open abdominal hysterectomy: a randomized controlled trial. BMC Anesthesiol. 2024 Jun 7;24(1):202. doi: 10.1186/s12871-024-02571-0.
PubMed 38849734
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Ibuprofen Versus Ketorolac for Perioperative Pain Control After Open Hysterectomy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05610384
- Acronym / sponsor ID
- MD-246-2022
- Conditions
- Postoperative Pain, Hysterectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Nov 2022 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 16 May 2023 (actual)
- First posted
- 9 Nov 2022 (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 compare the analgesic effect of intravenous ibuprofen to ketorolac for pain control after open hysterectomy
Detailed description
Thirty minutes before the surgery, all patients will receive 1 gm paracetamol intravenously then every 6 hours postoperatively.
A research assistant is responsible for opening the envelopes, group assignment and drug preparation (the three doses will be prepared and marked with the patient's name as well as the time of administration) without any further involvement in the study. The patient, attending anesthetist, nurse and data collector will be blinded to the administered drug.
Upon arrival to the operating room, routine monitors (electrocardiogram, pulse oximetry, and non-invasive blood pressure monitor) will be applied; intravenous line will be secured, and prophylactic antiemetic will be provided in the form of slow intravenous injection of 8 mg dexamethasone drugs.
Anesthesia Anesthesia will be induced with 2 mg/kg propofol, 1 mcg/kg fentanyl, and tracheal intubation will be facilitated by 0.5 mg/kg atracurium after loss of consciousness. Anesthesia will be maintained with isoflurane 1-1.2% in oxygen and 0.1 mg/kg atracurium every 20 minutes. Intraoperative analgesia will be in the form of 1 mcg/kg fentanyl boluses as needed.
Postoperatively, pain assessments using the visual analogue scale (VAS) will be performed at rest and during movement (knee flexion) at 0.5, 2, 4, 6, 10, 18, and 24 h after leaving the operating room. If the VAS score is > 3 intravenous titration of 2 mg morphine given slowly to be repeated after 30 minutes if pain persisted.
Intravenous ondansetron 4 mg will be given to treat postoperative nausea or vomiting
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketorolac group | Active comparator | Drug: Ketorolac Injectable Solutionketorolac 30 mg |
| Ibuprofen group | Active comparator | Drug: Ibuprofen 800 mgibuprofen 800 mg |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult (40-65 years)
- ASA I-II women
- scheduled to undergo open elective abdominal hysterectomy with or without salpingo-oophorectomy
Key exclusion criteria (7 listed)
- renal impairment,
- allergy to any of study's drugs,
- history of gastrointestinal bleeding or ulceration, or inflammatory bowel disease,
- severe cardiac comorbidity (impaired contractility with ejection fraction < 50%, heart block, significant arrhythmias, tight valvular lesions),
- patients undergoing surgery for suspected gynaecological cancer,
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 |
|---|---|---|
| Ketorolac Injectable Solutionketorolac 30 mg (diluted in 200 mL normal saline) intravenously over 5 minutes before induction of anesthesia then every 8 hours postoperatively | Drug | Ketorolac group |
| Ibuprofen 800 mgibuprofen 800 mg intravenously (Diluted in 200 mL of normal saline) over 5 minutes before induction of anesthesia then every 8 hours postoperatively. | Drug | Ibuprofen group |
Primary outcome
mean dynamic VAS
Time frame: 24 hour after surgery
average postoperative VAS
6 secondary outcomes
static VAS
Time frame: 30 minutes, 2, 4, 6, 10, 18, 24 hours postoperatively
dynamic VAS
Time frame: procedure (during knee flexion)
time to first analgesia requirement
Time frame: period from extubation until first analgesic requirement during the first 24 hour postoperatively
morphine consumption
Time frame: during the first 24 hour postoperatively
time to independent movement
Time frame: during the first 24 hour postoperatively
patients satisfaction
Time frame: at the end of 24 hour postoperative
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 27 Jul 2023.
- Derived from this study: PubMed 38849734Amin S, Hasanin A, Attia OA, Mostafa M, Elzayat NS, Elsherbiny M, Eissa AA. Intravenous ibuprofen versus ketorolac for perioperative pain control in open abdominal hysterectomy: a randomized controlled trial. BMC Anesthesiol. 2024 Jun 7;24(1):202. doi: 10.1186/s12871-024-02571-0.
- Individual participant dataSharing planned: No. data will be share upon reasonable request from the PI
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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 Ketorolac Injectable Solution and Ibuprofen 800 mg in people with Postoperative Pain and Hysterectomy, 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 3 inclusion and 7 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 27 Jul 2023. 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?
mean dynamic VAS (time frame: 24 hour after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05610384, which also lists 1 linked publication.
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 27 Jul 2023.