Spinal FusionPhase 2NCT06067893
Low Dose Dexmedetomidine as a Postoperative Pain Adjunct
A Phase 2 study testing Dexmedetomidine and Normal Saline in people with Spinal Fusion and Adolescent Idiopathic Scoliosis, run by Nichole Doyle at 1 site in United States.
Trial summary
This randomized controlled trial examines whether the addition of a low-dose dexmedetomidine infusion to our current multimodal pain management plan decreases narcotic consumption and reduces side effects in adolescent patients undergoing posterior spinal fusion for idiopathic scoliosis. Read more about this study
- Who is it for?
- Ages 10 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Fusion, Adolescent Idiopathic Scoliosis
- What is being tested?
- Dexmedetomidine and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to Jul 2027
- Phase
- Phase 2
- 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 10 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Diagnosis of idiopathic scoliosis
- Undergoing a posterior spinal fusion of at least 5 levels with both thoracic and lumbar involvement
Who cannot join
- Known allergy to dexmedetomidine or any of the standard medications used intra or post operatively
- Patients with a history of chronic pain currently taking opioids, TCA's, Gabapentinoids
- Medical contraindications to administration of dexmedetomidine, unstable cardiac status, (prolonged Qtc, life threatening arrhythmias, use of digoxin)
- Moya Moya disease
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
Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
Official title: Dexmedetomidine as a Pain Management Adjunct in the Pediatric Population Undergoing Posterior Spinal Fusion
This randomized controlled trial examines whether the addition of a low-dose dexmedetomidine infusion to our current multimodal pain management plan decreases narcotic consumption and reduces side effects in adolescent patients undergoing posterior spinal fusion for idiopathic scoliosis.
Read the detailed description
Patients will assigned to one of two groups. Either the intervention group where they will receive a dexmedetomidine infusion at 0.2mcg/kg/hr for 24 hours post-operatively or the control group where they will receive a normal saline infusion for 24 hours post-operatively in addition to our hospitals standard pain management protocol. Pain scores will be recorded and patients will fill out a brief questionnaire on POD 1 about their pain control and side effects (pruritus, nausea, vomiting, drowsiness).
- Conditions
- Spinal Fusion, Adolescent Idiopathic Scoliosis
- Being tested
- Dexmedetomidine, Normal Saline
- Keywords
- Pain management, Narcotic sparing, Pediatric, Dexmedetomidine
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Patient receives dexmedetomidine for 48 hours post-operatively
Normal SalineDrug
Patient receives normal saline for 48 hours post-operatively
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | Patient receives low dose dexmedetomidine infusion in addition to normal post-operative pain management protocol Receives: Drug: Dexmedetomidine |
| Control | Placebo comparator | Patient receives normal saline infusion in addition to normal post-operative pain management protocol Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
narcotic consumption
measuring narcotic consumption in mg/kg per 24 hours in morphine equivalents
Measured: 48 hours post-operatively
Secondary outcomes (2)
Incidence of side effects (nausea, vomiting, pruritus)
Assessing the incidence of side effects (nausea, vomiting, pruritus) using a questionnaire and documented episodes of emesis
Measured: 48 hours post-operatively
Patient safety
Need to discontinue infusion due to over sedation (Ramsey score of 4 or greater), bradycardia (HR <50 sustained on 2 assessments or symptomatic), hypotension (SBP<85 on 2 consecutive assessments or symptomatic). If these HR and SBP safety parameters are not appropriate for a participant based on baseline measurements or medical history new limits will be entered in a nurse communication.
Measured: 24 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 posted5 Oct 2023
- Study start1 Jul 2024
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
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 Spinal FusionStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nichole Doyle
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nichole Doyle, Children's Mercy Hospital Kansas City
- Investigators
- Nichole M Doyle, MD, Principal investigator, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06067893
- Sponsor's protocol ID
- STUDY00002630
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2023
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Deidentified patient data available on request
Publications
Peng K, Zhang J, Meng XW, Liu HY, Ji FH. Optimization of Postoperative Intravenous Patient-Controlled Analgesia with Opioid-Dexmedetomidine Combinations: An Updated Meta-Analysis with Trial Sequential Analysis of Randomized Controlled Trials. Pain Physician. 2017 Nov;20(7):569-596.
PubMed 29149140Kaye AD, Chernobylsky DJ, Thakur P, Siddaiah H, Kaye RJ, Eng LK, Harbell MW, Lajaunie J, Cornett EM. Dexmedetomidine in Enhanced Recovery After Surgery (ERAS) Protocols for Postoperative Pain. Curr Pain Headache Rep. 2020 Apr 2;24(5):21. doi: 10.1007/s11916-020-00853-z.
PubMed 32240402Naduvanahalli Vivekanandaswamy A, Prasad Shetty A, Mugesh Kanna R, Shanmuganathan R. An analysis of the safety and efficacy of dexmedetomidine in posterior spinal fusion surgery for adolescent idiopathic scoliosis: a prospective randomized study. Eur Spine J. 2021 Mar;30(3):698-705. doi: 10.1007/s00586-020-06539-9. Epub 2020 Jul 21.
PubMed 32696258Panchgar V, Shetti AN, Sunitha HB, Dhulkhed VK, Nadkarni AV. The Effectiveness of Intravenous Dexmedetomidine on Perioperative Hemodynamics, Analgesic Requirement, and Side Effects Profile in Patients Undergoing Laparoscopic Surgery Under General Anesthesia. Anesth Essays Res. 2017 Jan-Mar;11(1):72-77. doi: 10.4103/0259-1162.200232.
PubMed 28298760
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine as a Pain Management Adjunct in the Pediatric Population Undergoing Posterior Spinal Fusion
- ClinicalTrials.gov ID
- NCT06067893
- Acronym / sponsor ID
- STUDY00002630
- Conditions
- Spinal Fusion, Adolescent Idiopathic Scoliosis
- Keywords
- Pain management, Narcotic sparing, Pediatric, Dexmedetomidine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Nichole DoyleUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 5 Oct 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.
This randomized controlled trial examines whether the addition of a low-dose dexmedetomidine infusion to our current multimodal pain management plan decreases narcotic consumption and reduces side effects in adolescent patients undergoing posterior spinal fusion for idiopathic scoliosis.
Detailed description
Patients will assigned to one of two groups. Either the intervention group where they will receive a dexmedetomidine infusion at 0.2mcg/kg/hr for 24 hours post-operatively or the control group where they will receive a normal saline infusion for 24 hours post-operatively in addition to our hospitals standard pain management protocol. Pain scores will be recorded and patients will fill out a brief questionnaire on POD 1 about their pain control and side effects (pruritus, nausea, vomiting, drowsiness).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: DexmedetomidinePatient receives low dose dexmedetomidine infusion in addition to normal post-operative pain management protocol |
| Control | Placebo comparator | Drug: Normal SalinePatient receives normal saline infusion in addition to normal post-operative pain management protocol |
Who may qualify
- Ages
- 10 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Diagnosis of idiopathic scoliosis
- Undergoing a posterior spinal fusion of at least 5 levels with both thoracic and lumbar involvement
Key exclusion criteria (4 listed)
- Known allergy to dexmedetomidine or any of the standard medications used intra or post operatively
- Patients with a history of chronic pain currently taking opioids, TCA's, Gabapentinoids
- Medical contraindications to administration of dexmedetomidine, unstable cardiac status, (prolonged Qtc, life threatening arrhythmias, use of digoxin)
- Moya Moya 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 |
|---|---|---|
| DexmedetomidinePatient receives dexmedetomidine for 48 hours post-operatively | Drug | Dexmedetomidine |
| Normal SalinePatient receives normal saline for 48 hours post-operatively | Drug | Control |
Primary outcome
narcotic consumption
Time frame: 48 hours post-operatively
measuring narcotic consumption in mg/kg per 24 hours in morphine equivalents
2 secondary outcomes
Incidence of side effects (nausea, vomiting, pruritus)
Time frame: 48 hours post-operatively
Patient safety
Time frame: 24 hours post-operatively
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 5 Oct 2026.
- Background: PubMed 29149140Peng K, Zhang J, Meng XW, Liu HY, Ji FH. Optimization of Postoperative Intravenous Patient-Controlled Analgesia with Opioid-Dexmedetomidine Combinations: An Updated Meta-Analysis with Trial Sequential Analysis of Randomized Controlled Trials. Pain Physician. 2017 Nov;20(7):569-596.
- Background: PubMed 32240402Kaye AD, Chernobylsky DJ, Thakur P, Siddaiah H, Kaye RJ, Eng LK, Harbell MW, Lajaunie J, Cornett EM. Dexmedetomidine in Enhanced Recovery After Surgery (ERAS) Protocols for Postoperative Pain. Curr Pain Headache Rep. 2020 Apr 2;24(5):21. doi: 10.1007/s11916-020-00853-z.
- Background: PubMed 32696258Naduvanahalli Vivekanandaswamy A, Prasad Shetty A, Mugesh Kanna R, Shanmuganathan R. An analysis of the safety and efficacy of dexmedetomidine in posterior spinal fusion surgery for adolescent idiopathic scoliosis: a prospective randomized study. Eur Spine J. 2021 Mar;30(3):698-705. doi: 10.1007/s00586-020-06539-9. Epub 2020 Jul 21.
- Background: PubMed 28298760Panchgar V, Shetti AN, Sunitha HB, Dhulkhed VK, Nadkarni AV. The Effectiveness of Intravenous Dexmedetomidine on Perioperative Hemodynamics, Analgesic Requirement, and Side Effects Profile in Patients Undergoing Laparoscopic Surgery Under General Anesthesia. Anesth Essays Res. 2017 Jan-Mar;11(1):72-77. doi: 10.4103/0259-1162.200232.
- Individual participant dataSharing planned: No. Deidentified patient data available on request
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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.
Nichole M Doyle, MD principal investigator
Children's Mercy Hospital Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexmedetomidine and Normal Saline in people with Spinal Fusion and Adolescent Idiopathic Scoliosis, run by Nichole Doyle 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 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: enrolling by invitation, as of the sponsor's last update on 5 Oct 2026. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
narcotic consumption (time frame: 48 hours post-operatively). 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 NCT06067893, 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 5 Oct 2026.