Distal Radius Fracture ReductionPhase 3NCT07120763
Pain Control Alternatives in Pediatric Patients With Distal Radius Fractures
A Phase 3 study testing Ketamine + Lidocaine, Ketamine group and Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray) in people with Distal Radius Fracture Reduction and Pain Control, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
The aim of this study is to evaluate the efficacy of a hematoma block and minimal ketamine pain control or hematoma block and intranasal fentanyl in pediatric patients presenting with distal radius fractures requiring reduction, compared to control of standard full conscious sedation using ketamine. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Distal Radius Fracture Reduction, Pain Control, Pediatric Fractures
- What is being tested?
- Ketamine + Lidocaine, Ketamine group and Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2025to 22 Aug 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children requiring reduction for distal radius fracture
- Children presenting to the emergency department
- Children who are ages 3 to 17 years.
Who cannot join
- Pediatric patients <3 years old
- Adult patients (i.e. ages 18 or up)
- Pediatric patients with injury patterns that are not amenable to hematoma block.
- Children who are not a candidate for sedation related to BMI > 95%tile for age, ASA class > 2, Mallampati score > 2, and pregnant patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Oshei Children's Hospital
Buffalo, New York, 14203
Dr. Tara Petroski Emergency Medicine Physician, MD, 716-323-2100, tpetroski@upa.chob.edu
About this study
The aim of this study is to evaluate the efficacy of a hematoma block and minimal ketamine pain control or hematoma block and intranasal fentanyl in pediatric patients presenting with distal radius fractures requiring reduction, compared to control of standard full conscious sedation using ketamine.
- Being tested
- Ketamine + Lidocaine, Ketamine group, Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine + LidocaineDrug
Including comparisons between patients randomized for treatment with full ketamine sedation in setting of distal radius fracture reduction, hematoma block/minimal ketamine pain control (. 0.25mg/kg) for distal radius fracture reduction, or intranasal fentanyl and hematoma block, utilized in the setting of distal radius fractures in pediatric patients requiring reduction
Ketamine groupDrug
Including comparisons between patients randomized for treatment with full ketamine sedation in setting of distal radius fracture reduction, hematoma block/minimal ketamine pain control (. 0.25mg/kg) for distal radius fracture reduction, or intranasal fentanyl and hematoma block, utilized in the setting of distal radius fractures in pediatric patients requiring reduction
Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)Drug
Also called fentanyl + lidocaine
Including comparisons between patients randomized for treatment with full ketamine sedation in setting of distal radius fracture reduction, hematoma block/minimal ketamine pain control (. 0.25mg/kg) for distal radius fracture reduction, or intranasal fentanyl and hematoma block, utilized in the setting of distal radius fractures in pediatric patients requiring reduction
| Study group | Role | What they receive |
|---|---|---|
| Full ketamine sedation | Active comparator | Including group of patients treated with full ketamine sedation in setting of distal radius fracture reduction Receives: Drug: Ketamine group |
| Hematoma block/minimal ketamine pain control | Active comparator | Including group of patients treated with hematoma block/minimal ketamine pain control (. 0.25mg/kg) for distal radius fracture reduction in pediatric patients requiring reduction Receives: Drug: Ketamine + Lidocaine |
| hematoma block/intranasal fentanyl | Active comparator | Including control group of patients treated with intranasal fentanyl and hematoma block, utilized in the setting of distal radius fractures in pediatric patients requiring reduction Receives: Drug: Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain control efficacy
Including control group of patients treated with full ketamine sedation in setting of distal radius fracture reduction; randomization of patients deemed safe for full sedation to either control group, or one of two intervention groups including (group 1) hematoma block/minimal ketamine pain control (0.25mg/kg), and (group 2) intranasal fentanyl and hematoma block, utilized in the setting of distal radius fractures in pediatric patients requiring reduction. The investigators will be obtaining Visual Analog Scale (VAS) pain scores for each group to determine pain control efficacy and to compare between groups. This is a numeric pain scale with associated faces to help children determine their pain level, with 0 being "no pain" (with a smiley/happy face) and 10 being "most pain possible" (with a sad/crying face).
Measured: 1 hour after fracture reduction is complete on the day of the procedure/study visit.
Patient satisfaction scores
Including control group of patients treated with full ketamine sedation in setting of distal radius fracture reduction; randomization of patients deemed safe for full sedation to either control group, or one of two intervention groups including (group 1) hematoma block/minimal ketamine pain control (0.25mg/kg), and (group 2) intranasal fentanyl and hematoma block, utilized in the setting of distal radius fractures in pediatric patients requiring reduction. The investigators will be obtaining patient satisfaction scores via a 5-point Likert scale to compare patient satisfaction between groups.
Measured: 1 hour after fracture reduction is complete on the day of the procedure/study visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start22 Aug 2025
- Primary completion22 Aug 2026 (estimated)
- Study completion22 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Distal Radius Fracture ReductionStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tara Petroski, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120763
- Sponsor's protocol ID
- STUDY00009073
- Status last verified
- Oct 2025
- First submitted
- 15 Apr 2025
- Last updated
- 10 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared. This is a single institution study; results will be shared after de-identification/analysis in the form of publication/presentation.
Publications
McCarty EC, Mencio GA, Walker LA, Green NE. Ketamine sedation for the reduction of children's fractures in the emergency department. J Bone Joint Surg Am. 2000 Jul;82-A(7):912-8. doi: 10.2106/00004623-200007000-00002.
PubMed 10901305Disel NR, Yilmaz HL, Sertdemir Y, Yesilagac H, Avci A. Etomidate Versus Ketamine: Effective Use in Emergency Procedural Sedation for Pediatric Orthopedic Injuries. Pediatr Emerg Care. 2016 Dec;32(12):830-834. doi: 10.1097/PEC.0000000000000373.
PubMed 25834964Jordan RW, Aquilina A, Westacott DJ, Cooke S. A comparison of ketamine sedation and general anaesthesia for manipulation of paediatric forearm fractures. Acta Orthop Belg. 2016 Dec;82(4):836-842.
PubMed 29182126Morrison T, Carender C, Kilbane B, Liu RW. Procedural Sedation With Ketamine Versus Propofol for Closed Reduction of Pediatric Both Bone Forearm Fractures. Orthopedics. 2017 Sep 1;40(5):288-294. doi: 10.3928/01477447-20170824-01. Epub 2017 Sep 7.
PubMed 28877328Kwong A, Aldridge ES, Jayawardana R, Brookwick A, Miller J, Buntine PG. Length of stay outcomes in patients receiving ketamine sedation versus Bier's block anaesthesia for procedural closed fracture reduction: A retrospective audit of paediatric emergency department patients. Emerg Med Australas. 2022 Feb;34(1):73-77. doi: 10.1111/1742-6723.13844. Epub 2021 Aug 29.
PubMed 34459117
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Control Alternatives in Pediatric Patients With Distal Radius Fractures
- ClinicalTrials.gov ID
- NCT07120763
- Acronym / sponsor ID
- STUDY00009073
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 22 Aug 2025 (actual)
- Primary completion
- 22 Aug 2026 (estimated)
- Study completion
- 22 Aug 2027 (estimated)
- First posted
- 13 Aug 2025 (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 evaluate the efficacy of a hematoma block and minimal ketamine pain control or hematoma block and intranasal fentanyl in pediatric patients presenting with distal radius fractures requiring reduction, compared to control of standard full conscious sedation using ketamine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Full ketamine sedation | Active comparator | Drug: Ketamine groupIncluding group of patients treated with full ketamine sedation in setting of distal radius fracture reduction |
| Hematoma block/minimal ketamine pain control | Active comparator | Drug: Ketamine + LidocaineIncluding group of patients treated with hematoma block/minimal ketamine pain control (. 0.25mg/kg) for distal radius fracture reduction in pediatric patients requiring reduction |
| hematoma block/intranasal fentanyl | Active comparator | Drug: Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)Including control group of patients treated with intranasal fentanyl and hematoma block, utilized in the setting of distal radius fractures in pediatric patients requiring reduction |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children requiring reduction for distal radius fracture
- Children presenting to the emergency department
- Children who are ages 3 to 17 years.
Key exclusion criteria (4 listed)
- Pediatric patients <3 years old
- Adult patients (i.e. ages 18 or up)
- Pediatric patients with injury patterns that are not amenable to hematoma block.
- Children who are not a candidate for sedation related to BMI > 95%tile for age, ASA class > 2, Mallampati score > 2, and pregnant 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 |
|---|---|---|
| Ketamine + LidocaineIncluding comparisons between patients randomized for treatment with full ketamine sedation in setting of distal radius fracture reduction, hematoma block/minimal ketamine pain control (. 0.25mg/kg) for distal radius fracture reduction, or intranasal fentanyl and hematoma block, utilized in the setting of distal radius fractures in pediatric patients requiring reduction | Drug | Hematoma block/minimal ketamine pain control |
| Ketamine groupIncluding comparisons between patients randomized for treatment with full ketamine sedation in setting of distal radius fracture reduction, hematoma block/minimal ketamine pain control (. 0.25mg/kg) for distal radius fracture reduction, or intranasal fentanyl and hematoma block, utilized in the setting of distal radius fractures in pediatric patients requiring reduction | Drug | Full ketamine sedation |
| Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)Also: fentanyl + lidocaineIncluding comparisons between patients randomized for treatment with full ketamine sedation in setting of distal radius fracture reduction, hematoma block/minimal ketamine pain control (. 0.25mg/kg) for distal radius fracture reduction, or intranasal fentanyl and hematoma block, utilized in the setting of distal radius fractures in pediatric patients requiring reduction | Drug | hematoma block/intranasal fentanyl |
Primary outcome
Pain control efficacy
Time frame: 1 hour after fracture reduction is complete on the day of the procedure/study visit.
Including control group of patients treated with full ketamine sedation in setting of distal radius fracture reduction; randomization of patients deemed safe for full sedation to either control group, or one of two intervention groups including (group 1) hematoma block/minimal ketamine pain control (0.25mg/kg), and (group 2) intranasal fentanyl and hematoma block, utilized in the setting of distal radius fractures in pediatric patients requiring reduction. The investigators will be obtaining Visual Analog Scale (VAS) pain scores for each group to determine pain control efficacy and to compare between groups. This is a numeric pain scale with associated faces to help children determine their pain level, with 0 being "no pain" (with a smiley/happy face) and 10 being "most pain possible" (with a sad/crying face).
Patient satisfaction scores
Time frame: 1 hour after fracture reduction is complete on the day of the procedure/study visit.
Including control group of patients treated with full ketamine sedation in setting of distal radius fracture reduction; randomization of patients deemed safe for full sedation to either control group, or one of two intervention groups including (group 1) hematoma block/minimal ketamine pain control (0.25mg/kg), and (group 2) intranasal fentanyl and hematoma block, utilized in the setting of distal radius fractures in pediatric patients requiring reduction. The investigators will be obtaining patient satisfaction scores via a 5-point Likert scale to compare patient satisfaction between groups.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2025.
- Background: PubMed 10901305McCarty EC, Mencio GA, Walker LA, Green NE. Ketamine sedation for the reduction of children's fractures in the emergency department. J Bone Joint Surg Am. 2000 Jul;82-A(7):912-8. doi: 10.2106/00004623-200007000-00002.
- Background: PubMed 25834964Disel NR, Yilmaz HL, Sertdemir Y, Yesilagac H, Avci A. Etomidate Versus Ketamine: Effective Use in Emergency Procedural Sedation for Pediatric Orthopedic Injuries. Pediatr Emerg Care. 2016 Dec;32(12):830-834. doi: 10.1097/PEC.0000000000000373.
- Background: PubMed 29182126Jordan RW, Aquilina A, Westacott DJ, Cooke S. A comparison of ketamine sedation and general anaesthesia for manipulation of paediatric forearm fractures. Acta Orthop Belg. 2016 Dec;82(4):836-842.
- Background: PubMed 28877328Morrison T, Carender C, Kilbane B, Liu RW. Procedural Sedation With Ketamine Versus Propofol for Closed Reduction of Pediatric Both Bone Forearm Fractures. Orthopedics. 2017 Sep 1;40(5):288-294. doi: 10.3928/01477447-20170824-01. Epub 2017 Sep 7.
- Background: PubMed 34459117Kwong A, Aldridge ES, Jayawardana R, Brookwick A, Miller J, Buntine PG. Length of stay outcomes in patients receiving ketamine sedation versus Bier's block anaesthesia for procedural closed fracture reduction: A retrospective audit of paediatric emergency department patients. Emerg Med Australas. 2022 Feb;34(1):73-77. doi: 10.1111/1742-6723.13844. Epub 2021 Aug 29.
- Individual participant dataSharing planned: No. IPD will not be shared. This is a single institution study; results will be shared after de-identification/analysis in the form of publication/presentation.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketamine + Lidocaine, Ketamine group and Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray) in people with Distal Radius Fracture Reduction and Pain Control, run by State University of New York at Buffalo at 1 site in United States.
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 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: looking for participants now, as of the sponsor's last update on 10 Oct 2025. 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 United States. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Ellen Lutnick Lutnick, MD ((716) 323-2100, ellenlut@buffalo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain control efficacy (time frame: 1 hour after fracture reduction is complete on the day of the procedure/study visit.). The study lists 2 primary outcomes in all. 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 NCT07120763, which also lists 5 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 10 Oct 2025.