AnesthesiaPhase 2DEXPEDNCT06736483
Intravenous Dexmedetomidine as an Adjuvant to Locoregional Anesthesia in Pediatric Surgery
A Phase 2 study testing Dexmedetomidine, Face Legs Activity Cry Consolability scale and Post-Hospitalization Behavior Questionnaire in people with Anesthesia and Pediatric Surgery, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The main objective of this study is to study the impact of intravenous dexmedetomidine combined with locoregional anesthesia on postoperative pain in children undergoing surgery. Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Anesthesia, Pediatric Surgery
- What is being tested?
- Dexmedetomidine, Face Legs Activity Cry Consolability scale and Post-Hospitalization Behavior Questionnaire
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 3 Feb 2025to 3 Jul 2028
- 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 1 year to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 1 to 7 years old male or female
- To be hospitalized for scheduled urovisceral orchidopexy or peritoneovaginal canal surgery (inguinal hernia or hydrocele cure) on an outpatient basis
- Local-regional anesthesia via Transversus Abdominis Plane (TAP) block and/or pudendal block
- National health insurance coverage
- Have obtained signed informed consent from holders of parental authority
- American Society of Anesthesiology (ASA) score : 1-2
- French read, written and spoken by legal representatives
Who cannot join
- Patient under 1 or over 8 years old
- Patients with allergies to local anesthetics
- Patient with a contraindication to locoregional anesthesia: coagulation disorder or infection (fasciocutaneous) in the puncture zone
- Patients with a contraindication to dexmedetomidine (hypersensitivity to the active ingredient or one of the excipients, advanced heart block (level 2 or 3), uncontrolled hypotension, acute cerebrovascular pathologies)
- Patients with delayed psychological development, cognitive or behavioral disorders, or severe neurological pathology.
- Patients and/or parents who refused to participate in the study
- Proven allergy or contraindication to dexmedetomidine or nalbuphine
- Previous study participants
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
UH of Montpellier
Montpellier, France, 34295
Julien PICO, MD, j-pico@chu-montpellier.fr
About this study
Official title: Intravenous Dexmedetomidine as an Adjuvant to Locoregional Anesthesia in Pediatric Surgery: a Prospective, Randomized, Double-blind, Placebo-controlled Study. DEXPED
The main objective of this study is to study the impact of intravenous dexmedetomidine combined with locoregional anesthesia on postoperative pain in children undergoing surgery.
Secondary objectives was to compare beetwen groups : Post-operative pain; opioid consumption; incidence of emergence delirium, post-operative behavioral disorders, length of stay in the PACU, adverse events , parental satisfaction and quality of life.The goal of this clinical trial is to assess intravenous dexmedetomidine to prevent post-operative pain in children undergoing surgery.
Read more
This study is prospective and children will be randomized in one of the following arm:
- Dexmedetomidine (experimental treatment)
- Placebo The experimental treatment or placebo will be administrated at one time point at the time of incision.
Participants and their legal representative will have to respond to questionnaires at several time points following the surgery: Day 1, Week 1, Month 3 and Month 6.
Read the detailed description
Postoperative pain, which can develop into chronic pain in children, can have a significant impact on the quality of life of the child and their parents. Management of acute postoperative pain is crucial to prevent chronic pain, and perioperative opioid sparing aims to reduce opioid side effects. The emergence of postoperative delirium (ED) is also a concern, as it can cause intense agitation and diagnostic difficulties. Dexmedetomidine, in addition to its sedative and analgesic effects, has been shown to prolong the duration and effectiveness of regional anesthesia (LAR), thereby reducing the need for opioids and attenuating the severity of postoperative delirium. Its use in these settings could improve pain management and reduce complications associated with pediatric surgery, thus offering a promising therapeutic option.
- Conditions
- Anesthesia, Pediatric Surgery
- Being tested
- Dexmedetomidine, Placebo administration, Face Legs Activity Cry Consolability scale, Post-Hospitalization Behavior Questionnaire, Postoperative pain measure
- Keywords
- loco-regional anesthesia, Pain, Emergence delirium
- Medical subject headings
- Pain, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Intravenous administration of 1 µg /kg of dexmedetomidine in 10 ml of 0.9% sodium chloride at the time of incision.
Placebo administrationDrug
Intravenous administration of 10 ml sodium chloride 0.9% at the time of incision
Face Legs Activity Cry Consolability scaleOther
The pain will be assessed on admission and every 15 minutes until discharge from the PACU
Post-Hospitalization Behavior QuestionnaireOther
The Post-Hospitalization Behavior Questionnaire will be completed at day 1 and at day 7
Postoperative pain measureOther
The Postoperative pain measure will be completed by parents at day 1, day 7, 3 months and 6 months
Post-operative quality of life questionnaireOther
The Post-operative quality of life questionnaire pedQL will be completed at 3 and 6 months
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | Intravenous administration of 1 µg /kg of dexmedetomidine in 10 ml of 0.9% sodium chloride at the time of incision. Receives: Drug: Dexmedetomidine; Other: Face Legs Activity Cry Consolability scale; Other: Post-Hospitalization Behavior Questionnaire; Other: Postoperative pain measure; Other: Post-operative quality of life questionnaire |
| Placebo | Placebo comparator | Intravenous administration of 10 ml sodium chloride 0.9% at the time of incision Receives: Drug: Placebo administration; Other: Face Legs Activity Cry Consolability scale; Other: Post-Hospitalization Behavior Questionnaire; Other: Postoperative pain measure; Other: Post-operative quality of life questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rescue analgesic
Rescue analgesic (Nalbuphine, Nubain®) administration in the PACU between the 2 arms.
Measured: From the end of surgery to hospital discharge (up to 7 days)
Secondary outcomes (10)
Postoperative pain
Assessment of postoperative pain using the Face Legs Activity Cry Consolability (FLACC) scale: on admission and every 15 minutes until discharge from the PACU, then before returning home.
Measured: From the end of surgery to hospital discharge (up to 2 days)
Intraoperative morphine consumption
Measured: From anesthesia induction to the end of surgery (up to 24 hours)
Emergency analgesics
Dose in milligrams of emergency analgesics in the PACU
Measured: From the end of surgery to hospital discharge (up to 24 hours)
Adverse events
Incidence of opioid-related side effects (respiratory complications - postoperative nausea and vomiting)
Measured: From the end of surgery up to 7 postoperative days
Length of hospital stay
Length of hospital stay in hours from admission to discharge
Measured: From the start of hospitalization to hospital discharge (up to 7 days)
Ped-PADSS score
The Post-Anesthetic Discharge Scoring System aimed to assess the possibility of discharge. The minimum is 0 and the maximum 10. A score of 9 or 10 authorizes hospital discharge.
Measured: From the end of surgery to hospital discharge (up to 2 days)
Pediatric Anesthesia Emergence Delirium
Incidence of emergence of delirium in the PACU according to the Pediatric Anesthesia Emergence Delirium (PAED) scale. Score from 0 to 20, a score > 9 indicates an emergence delirium
Measured: From the end of surgery to hospital discharge (up to 24 hours)
Post-Hospitalization Behavior Questionnaire
Post-Hospitalization Behavior Questionnaire at day 1 and day 7. This questionnaire is composed of 27 items rated from 1 to 5, minimum score : 27, maximum score: 135. A score above 68 is associated with an increase in postoperative behavioral problems.
Measured: From the end of surgery up to 6 postoperative months
Postoperative Pain Measure For Parents
Postoperative Pain Measure For Parents at 7 days, 3 and 6 months. Score: from 0 to 10 with 10 items. A score above 6 indicates significant pain.
Measured: From the end of surgery up to 6 postoperative months
Post-operative quality of life questionnaire
Post-operative quality of life questionnaire pedsQL at 3 and 6 months. The 23 questions cover 4 different domains: physical functioning (8 items), emotional functioning (5 items), social functioning (5 items) and academic functioning (5 items).
The parent questionnaire assesses parents' perceptions of their child's health-related quality of life.
Measured: From the end of surgery up to 6 postoperative months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start3 Feb 2025
- Primary completion3 Jul 2028 (estimated)
- Study completion3 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736483
- Sponsor's protocol ID
- RECHMPL23_0433
- Other IDs
- 2024-514550-73-00
- Acronym
- DEXPED
- Status last verified
- Oct 2026
- First submitted
- 5 Dec 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Dexmedetomidine as an Adjuvant to Locoregional Anesthesia in Pediatric Surgery: a Prospective, Randomized, Double-blind, Placebo-controlled Study. DEXPED
- ClinicalTrials.gov ID
- NCT06736483
- Acronym / sponsor ID
- DEXPED / RECHMPL23_0433
- Conditions
- Anesthesia, Pediatric Surgery
- Keywords
- loco-regional anesthesia, Pain, Emergence delirium
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 3 Jul 2028 (estimated)
- Study completion
- 3 Jul 2028 (estimated)
- First posted
- 16 Dec 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.
The main objective of this study is to study the impact of intravenous dexmedetomidine combined with locoregional anesthesia on postoperative pain in children undergoing surgery.
Secondary objectives was to compare beetwen groups : Post-operative pain; opioid consumption; incidence of emergence delirium, post-operative behavioral disorders, length of stay in the PACU, adverse events , parental satisfaction and quality of life.The goal of this clinical trial is to assess intravenous dexmedetomidine to prevent post-operative pain in children undergoing surgery.
This study is prospective and children will be randomized in one of the following arm:
- Dexmedetomidine (experimental treatment)
- Placebo The experimental treatment or placebo will be administrated at one time point at the time of incision.
Participants and their legal representative will have to respond to questionnaires at several time points following the surgery: Day 1, Week 1, Month 3 and Month 6.
Detailed description
Postoperative pain, which can develop into chronic pain in children, can have a significant impact on the quality of life of the child and their parents. Management of acute postoperative pain is crucial to prevent chronic pain, and perioperative opioid sparing aims to reduce opioid side effects. The emergence of postoperative delirium (ED) is also a concern, as it can cause intense agitation and diagnostic difficulties. Dexmedetomidine, in addition to its sedative and analgesic effects, has been shown to prolong the duration and effectiveness of regional anesthesia (LAR), thereby reducing the need for opioids and attenuating the severity of postoperative delirium. Its use in these settings could improve pain management and reduce complications associated with pediatric surgery, thus offering a promising therapeutic option.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: Dexmedetomidine, Other: Face Legs Activity Cry Consolability scale, Other: Post-Hospitalization Behavior Questionnaire, Other: Postoperative pain measure, Other: Post-operative quality of life questionnaireIntravenous administration of 1 µg /kg of dexmedetomidine in 10 ml of 0.9% sodium chloride at the time of incision. |
| Placebo | Placebo comparator | Drug: Placebo administration, Other: Face Legs Activity Cry Consolability scale, Other: Post-Hospitalization Behavior Questionnaire, Other: Postoperative pain measure, Other: Post-operative quality of life questionnaireIntravenous administration of 10 ml sodium chloride 0.9% at the time of incision |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age 1 to 7 years old male or female
- To be hospitalized for scheduled urovisceral orchidopexy or peritoneovaginal canal surgery (inguinal hernia or hydrocele cure) on an outpatient basis
- Local-regional anesthesia via Transversus Abdominis Plane (TAP) block and/or pudendal block
- National health insurance coverage
- Have obtained signed informed consent from holders of parental authority
Key exclusion criteria (8 listed)
- Patient under 1 or over 8 years old
- Patients with allergies to local anesthetics
- Patient with a contraindication to locoregional anesthesia: coagulation disorder or infection (fasciocutaneous) in the puncture zone
- Patients with a contraindication to dexmedetomidine (hypersensitivity to the active ingredient or one of the excipients, advanced heart block (level 2 or 3), uncontrolled hypotension, acute cerebrovascular pathologies)
- Patients with delayed psychological development, cognitive or behavioral disorders, or severe neurological pathology.
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 |
|---|---|---|
| DexmedetomidineIntravenous administration of 1 µg /kg of dexmedetomidine in 10 ml of 0.9% sodium chloride at the time of incision. | Drug | Dexmedetomidine |
| Placebo administrationIntravenous administration of 10 ml sodium chloride 0.9% at the time of incision | Drug | Placebo |
| Face Legs Activity Cry Consolability scaleThe pain will be assessed on admission and every 15 minutes until discharge from the PACU | Other | Dexmedetomidine, Placebo |
| Post-Hospitalization Behavior QuestionnaireThe Post-Hospitalization Behavior Questionnaire will be completed at day 1 and at day 7 | Other | Dexmedetomidine, Placebo |
| Postoperative pain measureThe Postoperative pain measure will be completed by parents at day 1, day 7, 3 months and 6 months | Other | Dexmedetomidine, Placebo |
| Post-operative quality of life questionnaireThe Post-operative quality of life questionnaire pedQL will be completed at 3 and 6 months | Other | Dexmedetomidine, Placebo |
Primary outcome
Rescue analgesic
Time frame: From the end of surgery to hospital discharge (up to 7 days)
Rescue analgesic (Nalbuphine, Nubain®) administration in the PACU between the 2 arms.
10 secondary outcomes
Postoperative pain
Time frame: From the end of surgery to hospital discharge (up to 2 days)
Intraoperative morphine consumption
Time frame: From anesthesia induction to the end of surgery (up to 24 hours)
Emergency analgesics
Time frame: From the end of surgery to hospital discharge (up to 24 hours)
Adverse events
Time frame: From the end of surgery up to 7 postoperative days
Length of hospital stay
Time frame: From the start of hospitalization to hospital discharge (up to 7 days)
Ped-PADSS score
Time frame: From the end of surgery to hospital discharge (up to 2 days)
Pediatric Anesthesia Emergence Delirium
Time frame: From the end of surgery to hospital discharge (up to 24 hours)
Post-Hospitalization Behavior Questionnaire
Time frame: From the end of surgery up to 6 postoperative months
Postoperative Pain Measure For Parents
Time frame: From the end of surgery up to 6 postoperative months
Post-operative quality of life questionnaire
Time frame: From the end of surgery up to 6 postoperative months
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 13 Oct 2026.
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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 2 study testing Dexmedetomidine, Face Legs Activity Cry Consolability scale and Post-Hospitalization Behavior Questionnaire in people with Anesthesia and Pediatric Surgery, run by University Hospital, Montpellier at 1 site in France.
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 7 inclusion and 8 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 13 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 France. 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?
Contact Julien PICO, MD (+33 7 88 01 44 14, j-pico@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rescue analgesic (time frame: From the end of surgery to hospital discharge (up to 7 days)). 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 13 Oct 2026.