Pain, PostoperativePhase 4NCT05523102
Paracetamol Compared With Ketorolac for Post-operative Analgetic
A Phase 4 study testing Paracetamol and Ketorolac in people with Pain, Postoperative, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
Post-operative analgetic modalities vary between center to center, especially in Indonesia. Considerations include potency/effectivity of the analgetics to achieve adequate pain control as soon as possible, reducing the total opioid dose intake and overall reducing potential opioid adverse effects. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Paracetamol and Ketorolac
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteIndonesia
- Study dates
- 31 Mar 2022to 2 Aug 2022
- Phase
- Phase 4
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Postoperative patients admitted to Neurosurgery HCU or PICU
- Parents/guardian signed informed consent forms
Who cannot join
- History of allergy to paracetamol and ketorolac
- Administration of opioid 24 hours before surgery
- Liver dysfunction
- Renal failure
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: Evaluation of Paracetamol as Post-operative Analgetic Modality Compared With Ketorolac
Post-operative analgetic modalities vary between center to center, especially in Indonesia. Considerations include potency/effectivity of the analgetics to achieve adequate pain control as soon as possible, reducing the total opioid dose intake and overall reducing potential opioid adverse effects. NSAID have been known to have more adverse effects than acetaminophen (paracetamol) but offers a higher potency for analgetic effects. Here the investigators compare whether paracetamol is adequate as a post-operative analgetics and confers fewer overall adverse effects when compared with ketorolac (NSAID)
Read the detailed description
OBJECTIVE: The purpose of this study was to compare the efficacy of Ketorolac versus Paracetamol as an adjunct to Nalbuphine in the management of post-operative pain following elective cardiac surgery.
STUDY DESIGN: Randomized (single-blind) control trial.
SAMPLING TECHNIQUE: Computer generated, randomized selection of patients with 50% probability of assignment into either group.
PLACE AND STUDY DURATION: (single center) PICU and Neurosurgery HCU at the Cipto Mangunkusumo National Referral Center Hospital, Jakarat, Indonesia, over a period of 6 months, from March to August 2022.
METHODS: Eighty-five patients (46 in paracetamol group and 39 in ketorolac group) were randomly assigned to receive either Paracetamol (treatment) or Ketorolac (control), along with the usual pre and intraoperative sedative/analgetics, and opioid as indicated over the first 48 hours postoperatively. The treatment group received injection Paracetamol 15mg/kg six hourly, whereas control group received injection Ketorolac 0.5mg/kg eight hourly.
PRIMARY OUTCOME: The rFLACC (pain score) was evaluated at 0, 8, 12, 24 and 48 hours post-operation and a score of 4 or less was taken as a cut-off for adequate pain control.
SECONDARY OUTCOMES: The total dose of opioid administered to each patient and adverse effects
- Conditions
- Pain, Postoperative
- Being tested
- Paracetamol, Ketorolac
- Keywords
- Acetaminophen, Ketorolac, Postoperative pain, Pediatric, NSAID, Paracetamol, Opioid, Morphine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacetamolDrug
Also called Acetaminophen
Intravenous paracetamol/acetaminophen
KetorolacDrug
Also called NSAID
Intravenous ketorolac/NSAID
| Study group | Role | What they receive |
|---|---|---|
| Paracetamol | Experimental | Paracetamol 15mg/kg 6 hourly for 48 hours post-operatively Receives: Drug: Paracetamol |
| Ketorolac | Active comparator | Ketorolac 0.5mg/kg 8 hourly for 48 hours post-operatively Receives: Drug: Ketorolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain change
Post operative analgesic assessment using rFLACC: a pain scoring used primarily for unconscious or disabled children. 0 no pain at all, 10: worst pain (range 0 - 10) Grading is based on the clinical and subjective signs defined in the scoring. For the purposes of this study "adequate pain relief" was defined as achieving a pain score of four or less.
Measured: Total 48 hours (0, 8, 12, 24 and 48 hours) post operation
Secondary outcomes (2)
Change in Opioid usage
Change in opioid administration as an opioid analgesic
Measured: 48 hours post operatively
Adverse effects
Increase of ALT/AST 3 times above normal range, AKI risk stage, gastrointestinal bleeding
Measured: 48 hours post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start31 Mar 2022
- Primary completion18 Jul 2022
- Study completion2 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Computer generated, randomized selection of patients with 50% probability of assignment into either group Treatment group : paracetamol group Control Group: ketorolac
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- Dr Cipto Mangunkusumo General Hospital
- Responsible party
- Principal investigator, Radhian Amandito, Universitas Indonesia
- Investigators
- Rismala Dewi, Prof, Study chair, Fakultas Kedokteran Universitas IndonesiaBernie E Medise, Dr, Study chair, Fakultas Kedokteran Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523102
- Sponsor's protocol ID
- 0254
- Status last verified
- Aug 2022
- First submitted
- 29 Aug 2022
- Last updated
- 6 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Paracetamol as Post-operative Analgetic Modality Compared With Ketorolac
- ClinicalTrials.gov ID
- NCT05523102
- Acronym / sponsor ID
- 0254
- Conditions
- Pain, Postoperative
- Keywords
- Acetaminophen, Ketorolac, Postoperative pain, Pediatric, NSAID, Paracetamol, Opioid, Morphine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Collaborators
- Dr Cipto Mangunkusumo General Hospital
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 18 Jul 2022 (actual)
- Study completion
- 2 Aug 2022 (actual)
- First posted
- 31 Aug 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.
Post-operative analgetic modalities vary between center to center, especially in Indonesia. Considerations include potency/effectivity of the analgetics to achieve adequate pain control as soon as possible, reducing the total opioid dose intake and overall reducing potential opioid adverse effects. NSAID have been known to have more adverse effects than acetaminophen (paracetamol) but offers a higher potency for analgetic effects. Here the investigators compare whether paracetamol is adequate as a post-operative analgetics and confers fewer overall adverse effects when compared with ketorolac (NSAID)
Detailed description
OBJECTIVE: The purpose of this study was to compare the efficacy of Ketorolac versus Paracetamol as an adjunct to Nalbuphine in the management of post-operative pain following elective cardiac surgery.
STUDY DESIGN: Randomized (single-blind) control trial.
SAMPLING TECHNIQUE: Computer generated, randomized selection of patients with 50% probability of assignment into either group.
PLACE AND STUDY DURATION: (single center) PICU and Neurosurgery HCU at the Cipto Mangunkusumo National Referral Center Hospital, Jakarat, Indonesia, over a period of 6 months, from March to August 2022.
METHODS: Eighty-five patients (46 in paracetamol group and 39 in ketorolac group) were randomly assigned to receive either Paracetamol (treatment) or Ketorolac (control), along with the usual pre and intraoperative sedative/analgetics, and opioid as indicated over the first 48 hours postoperatively. The treatment group received injection Paracetamol 15mg/kg six hourly, whereas control group received injection Ketorolac 0.5mg/kg eight hourly.
PRIMARY OUTCOME: The rFLACC (pain score) was evaluated at 0, 8, 12, 24 and 48 hours post-operation and a score of 4 or less was taken as a cut-off for adequate pain control.
SECONDARY OUTCOMES: The total dose of opioid administered to each patient and adverse effects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Computer generated, randomized selection of patients with 50% probability of assignment into either group Treatment group : paracetamol group Control Group: ketorolac
| Arm | Type | Receives |
|---|---|---|
| Paracetamol | Experimental | Drug: ParacetamolParacetamol 15mg/kg 6 hourly for 48 hours post-operatively |
| Ketorolac | Active comparator | Drug: KetorolacKetorolac 0.5mg/kg 8 hourly for 48 hours post-operatively |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Postoperative patients admitted to Neurosurgery HCU or PICU
- Parents/guardian signed informed consent forms
Key exclusion criteria (4 listed)
- History of allergy to paracetamol and ketorolac
- Administration of opioid 24 hours before surgery
- Liver dysfunction
- Renal failure
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 |
|---|---|---|
| ParacetamolAlso: AcetaminophenIntravenous paracetamol/acetaminophen | Drug | Paracetamol |
| KetorolacAlso: NSAIDIntravenous ketorolac/NSAID | Drug | Ketorolac |
Primary outcome
Pain change
Time frame: Total 48 hours (0, 8, 12, 24 and 48 hours) post operation
Post operative analgesic assessment using rFLACC: a pain scoring used primarily for unconscious or disabled children. 0 no pain at all, 10: worst pain (range 0 - 10) Grading is based on the clinical and subjective signs defined in the scoring. For the purposes of this study "adequate pain relief" was defined as achieving a pain score of four or less.
2 secondary outcomes
Change in Opioid usage
Time frame: 48 hours post operatively
Adverse effects
Time frame: 48 hours post operatively
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 6 Sep 2022.
- 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.
Rismala Dewi, Prof study chair
Fakultas Kedokteran Universitas Indonesia
Bernie E Medise, Dr study chair
Fakultas Kedokteran Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paracetamol and Ketorolac in people with Pain, Postoperative, run by Universitas Indonesia at 1 site in Indonesia.
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 2 inclusion and 4 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 6 Sep 2022. 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 Indonesia. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 change (time frame: Total 48 hours (0, 8, 12, 24 and 48 hours) post operation). 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 6 Sep 2022.