Postoperative Pain, AcutePhase 4KVFPTNCT06630364
Comparing Ketamine and Fentanyl in Pediatric Tonsillectomy: Pain Control and Emergence Delirium Outcomes (KVFPT)
A Phase 4 study testing ketamine and fentanyl in people with Postoperative Pain, Acute and Emergence Delirium, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
This study is designed to compare the effectiveness of two medications, ketamine and fentanyl, in managing pain and preventing delirium in children aged 3 to 8 years who are undergoing tonsillectomy and adenoidectomy surgery. Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Postoperative Pain, Acute, Emergence Delirium
- What is being tested?
- ketamine and fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 15 Jun 2024
- 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 3 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 3 to 8 years
- Scheduled for tonsillectomy and adenoidectomy
- American Society of Anesthesiologists (ASA) Physical Status I-III
Who cannot join
- American Society of Anesthesiologists' Physical Status ≥4
- Known hypersensitivity or allergy to any of the study medications (acetaminophen, ketamine, fentanyl)
- Receiving chronic opioid analgesic therapy prior to surgery
- Renal disease
- Hepatic disease
- Obesity (body mass index greater than 99th percentile for age)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Medipol Mega University Hospital
Istanbul, Bagcılar, 34214
About this study
Official title: A Randomized Clinical Trial Comparing Ketamine and Fentanyl for Postoperative Pain Management and Emergence Delirium Following Pediatric Tonsillectomy and Adenoidectomy
This study is designed to compare the effectiveness of two medications, ketamine and fentanyl, in managing pain and preventing delirium in children aged 3 to 8 years who are undergoing tonsillectomy and adenoidectomy surgery. The study aims to determine which medication is better at reducing pain and preventing delirium after surgery, and which one results in faster recovery times and fewer side effects. Children participating in the study will be randomly assigned to receive either ketamine or fentanyl during their surgery. The study will measure pain levels, recovery times, and any side effects experienced by the children. The results of this study will help doctors and anesthesiologists make better decisions about which medication to use for pain management in children undergoing tonsillectomy and adenoidectomy.
- Conditions
- Postoperative Pain, Acute, Emergence Delirium
- Keywords
- Tonsillectomy, Adenoidectomy, Postoperative pain management, Emergence delirium, Ketamine, Fentanyl
- Medical subject headings
- Pain, Postoperative, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketamineDrug
Induction: Sevoflurane in N2O/O2, Propofol (1-1.5 mg/kg) Analgesia: Ketamine (0.5 mg/kg) Maintenance: Sevoflurane
fentanylDrug
Induction: Sevoflurane in N2O/O2 Analgesia: Propofol (1-1.5 mg/kg), Fentanyl (1 µg/kg) Maintenance: Sevoflurane
| Study group | Role | What they receive |
|---|---|---|
| Group I (Ketamine group) | Active comparator | The patients in this group will have intravenous ketamine (0.5 mg/kg) during induction Receives: Drug: ketamine |
| Group II (Fentanyl Group) | Experimental | The patients in this group will have intravenous fentanyl (1 µg/kg) during induction Receives: Drug: fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores
Face, Legs, Activity, Cry, Consolability (FLACC) Scale Range: 0 to 10 Higher scores indicate worse pain 0 = no pain, 10 = worst possible pain (Assessment of Behavioural Score: ; 0 = Relaxed and comfortable ; 1-3 = Mild discomfort ; 4-6 = Moderate pain ; 7-10 = Severe discomfort/pain.)
Measured: From the enrollment to 8 hours post-surgery
Secondary outcomes (1)
Incidence of Emergence Delirium Following Pediatric Tonsillectomy and Adenoidectomy
Pediatric Anesthesia Emergence Delirium (PAED) Scale Range: 0 to 20 Higher scores indicate more severe emergence delirium 0 = no delirium, 20 = extreme delirium
Measured: From the enrollment to 8 hours post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start1 Jan 2023
- Primary completion1 May 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pain, AcuteStudies of the same condition, open and under way.
- More trials run by Medipol 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul Medipol University Hospital
- Responsible party
- Principal investigator, Yunus Oktay Atalay, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06630364
- Sponsor's protocol ID
- E-10840098-772.02-4354Karar651
- Other IDs
- Istanbul Medipol University
- Acronym
- KVFPT
- Status last verified
- Oct 2024
- First submitted
- 4 Oct 2024
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdelhalim AA, Alarfaj AM. The effect of ketamine versus fentanyl on the incidence of emergence agitation after sevoflurane anesthesia in pediatric patients undergoing tonsillectomy with or without adenoidectomy. Saudi J Anaesth. 2013 Oct;7(4):392-8. doi: 10.4103/1658-354X.121047.
PubMed 24348289Michelet D, Hilly J, Skhiri A, Abdat R, Diallo T, Brasher C, Dahmani S. Opioid-Sparing Effect of Ketamine in Children: A Meta-Analysis and Trial Sequential Analysis of Published Studies. Paediatr Drugs. 2016 Dec;18(6):421-433. doi: 10.1007/s40272-016-0196-y.
PubMed 27688125Eghbal MH, Taregh S, Amin A, Sahmeddini MA. Ketamine improves postoperative pain and emergence agitation following adenotonsillectomy in children. A randomized clinical trial. Middle East J Anaesthesiol. 2013 Jun;22(2):155-60.
PubMed 24180163Alghamdi F, Roth C, Jatana KR, Elmaraghy CA, Rice J, Tobias JD, Thung AK. Opioid-Sparing Anesthetic Technique for Pediatric Patients Undergoing Adenoidectomy: A Pilot Study. J Pain Res. 2020 Nov 19;13:2997-3004. doi: 10.2147/JPR.S281275. eCollection 2020.
PubMed 33239908
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial Comparing Ketamine and Fentanyl for Postoperative Pain Management and Emergence Delirium Following Pediatric Tonsillectomy and Adenoidectomy
- ClinicalTrials.gov ID
- NCT06630364
- Acronym / sponsor ID
- KVFPT / E-10840098-772.02-4354Karar651
- Conditions
- Postoperative Pain, Acute, Emergence Delirium
- Keywords
- Tonsillectomy, Adenoidectomy, Postoperative pain management, Emergence delirium, Ketamine, Fentanyl
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Collaborators
- Istanbul Medipol University Hospital
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 8 Oct 2024 (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.
This study is designed to compare the effectiveness of two medications, ketamine and fentanyl, in managing pain and preventing delirium in children aged 3 to 8 years who are undergoing tonsillectomy and adenoidectomy surgery. The study aims to determine which medication is better at reducing pain and preventing delirium after surgery, and which one results in faster recovery times and fewer side effects. Children participating in the study will be randomly assigned to receive either ketamine or fentanyl during their surgery. The study will measure pain levels, recovery times, and any side effects experienced by the children. The results of this study will help doctors and anesthesiologists make better decisions about which medication to use for pain management in children undergoing tonsillectomy and adenoidectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (Ketamine group) | Active comparator | Drug: ketamineThe patients in this group will have intravenous ketamine (0.5 mg/kg) during induction |
| Group II (Fentanyl Group) | Experimental | Drug: fentanylThe patients in this group will have intravenous fentanyl (1 µg/kg) during induction |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 3 to 8 years
- Scheduled for tonsillectomy and adenoidectomy
- American Society of Anesthesiologists (ASA) Physical Status I-III
Key exclusion criteria (6 listed)
- American Society of Anesthesiologists' Physical Status ≥4
- Known hypersensitivity or allergy to any of the study medications (acetaminophen, ketamine, fentanyl)
- Receiving chronic opioid analgesic therapy prior to surgery
- Renal disease
- Hepatic disease
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 |
|---|---|---|
| ketamineInduction: Sevoflurane in N2O/O2, Propofol (1-1.5 mg/kg) Analgesia: Ketamine (0.5 mg/kg) Maintenance: Sevoflurane | Drug | Group I (Ketamine group) |
| fentanylInduction: Sevoflurane in N2O/O2 Analgesia: Propofol (1-1.5 mg/kg), Fentanyl (1 µg/kg) Maintenance: Sevoflurane | Drug | Group II (Fentanyl Group) |
Primary outcome
Pain Scores
Time frame: From the enrollment to 8 hours post-surgery
Face, Legs, Activity, Cry, Consolability (FLACC) Scale Range: 0 to 10 Higher scores indicate worse pain 0 = no pain, 10 = worst possible pain (Assessment of Behavioural Score: ; 0 = Relaxed and comfortable ; 1-3 = Mild discomfort ; 4-6 = Moderate pain ; 7-10 = Severe discomfort/pain.)
1 secondary outcome
Incidence of Emergence Delirium Following Pediatric Tonsillectomy and Adenoidectomy
Time frame: From the enrollment to 8 hours post-surgery
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 30 Oct 2024.
- Background: PubMed 24348289Abdelhalim AA, Alarfaj AM. The effect of ketamine versus fentanyl on the incidence of emergence agitation after sevoflurane anesthesia in pediatric patients undergoing tonsillectomy with or without adenoidectomy. Saudi J Anaesth. 2013 Oct;7(4):392-8. doi: 10.4103/1658-354X.121047.
- Background: PubMed 27688125Michelet D, Hilly J, Skhiri A, Abdat R, Diallo T, Brasher C, Dahmani S. Opioid-Sparing Effect of Ketamine in Children: A Meta-Analysis and Trial Sequential Analysis of Published Studies. Paediatr Drugs. 2016 Dec;18(6):421-433. doi: 10.1007/s40272-016-0196-y.
- Background: PubMed 24180163Eghbal MH, Taregh S, Amin A, Sahmeddini MA. Ketamine improves postoperative pain and emergence agitation following adenotonsillectomy in children. A randomized clinical trial. Middle East J Anaesthesiol. 2013 Jun;22(2):155-60.
- Background: PubMed 33239908Alghamdi F, Roth C, Jatana KR, Elmaraghy CA, Rice J, Tobias JD, Thung AK. Opioid-Sparing Anesthetic Technique for Pediatric Patients Undergoing Adenoidectomy: A Pilot Study. J Pain Res. 2020 Nov 19;13:2997-3004. doi: 10.2147/JPR.S281275. eCollection 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.
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 Phase 4 study testing ketamine and fentanyl in people with Postoperative Pain, Acute and Emergence Delirium, run by Medipol University at 1 site in Turkey (Türkiye).
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 6 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 30 Oct 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 Turkey (Türkiye). 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 Scores (time frame: From the enrollment to 8 hours post-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 NCT06630364, which also lists 4 linked publications.
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 30 Oct 2024.