Trial · NCT02250703
Intranasal Dexmedetomidine Premedication in Children
NCT02250703, Phase 3, Completed, University of Mississippi Medical Center; results first posted 2017-07-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Intranasal Dexmedetomidine Premedication in Children. Trials, record NCT02250703. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02250703
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Intranasal Dexmedetomidine Premedication in Children
- NCT number
- NCT02250703
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 75 participants, actual
- Lead sponsor
- University of Mississippi Medical Center
- Conditions
- Preoperative Sedation
- Interventions
- Midazolam, Dexmedetomidine
- First posted
- 2014-09-26
- Last updated
- 2017-07-07
- Results first posted
- 2017-07-07
- Limitations and caveats
- All the consecutive patients were screened for eligibility. Patients were not selected on the basis of need for premedication.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | University of Michigan Sedation Scale | Day 0:Just before the patient will be brought to the operating room | Level of sedation at separation from parents and at the time of mask induction will be measured on a scale of 0 to 4 (University of Michigan Sedation Scale) University of Michigan Sedation Scale: 0 -Awake/Alert 1 -Minimally Sedated: Tired/sleepy, appropriate response to verbal conversation and/or sounds. 2- Moderately Sedated: Somnolent/sleeping, easily aroused with light tactile stimulation. 3 - Deeply Sedated: Deep sleep, arousable only with significant physical stimulation. 4 - Unarousable Moderately and Deeply sedated: Satisfactory Awake, minimally sedate, unarousable: Unsatisfactory |
| Secondary | Acceptance of Mask Induction | Day 0: At the time when anesthesia is induced | on a scale of 1 to 4 1. excellent( cooperative) 2. good( slight fear, easily calmed) 3. fair ( moderate fear, not calmed with reassurance) 4. Poor( agitated, terrified) 1 and 2 are considered satisfactory 3 and 4 are considered unsatisfactory |
| Secondary | Wake up Behavior | Day 0: At the end of surgery when the patient recovers from anesthesia | assessed in post anesthesia recovery unit after the procedure on a scale of 1o 4 1. calm 2. not calm but easily calmed 3. moderately agitated or restless 4. combative/disoriented 1 and 2 are considered satisfactory 3 and 4 are considered unsatisfactory |
| Secondary | Presence of Amnesia to Mask Induction | Day 0: at the time of discharge of the patient from the recovery room | Yes or No (if the patient remembers mask induction) |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | University of Michigan Sedation Scale | Day 0:Just before the patient will be brought to the operating room | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Acceptance of Mask Induction | Day 0: At the time when anesthesia is induced | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Wake up Behavior | Day 0: At the end of surgery when the patient recovers from anesthesia | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Presence of Amnesia to Mask Induction | Day 0: at the time of discharge of the patient from the recovery room | 7 patients in the M group and 5 patients in D group had significant developmental delay and could not answer the question regarding memory of mask induction. Thus, only 61 were analyzed for this part | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| University of Michigan Sedation Scale | Midazolam | Satisfactory sedation on separation from parents | 15 | Participants | |
| University of Michigan Sedation Scale | Dexmedetomidine | Satisfactory sedation on separation from parents | 25 | Participants | |
| University of Michigan Sedation Scale | Midazolam | Unsatisfactory sedation on separation from parents | 22 | Participants | |
| University of Michigan Sedation Scale | Dexmedetomidine | Unsatisfactory sedation on separation from parents | 11 | Participants | |
| University of Michigan Sedation Scale | Midazolam | Satisfactory sedation on transfer to OR table | 12 | Participants | |
| University of Michigan Sedation Scale | Dexmedetomidine | Satisfactory sedation on transfer to OR table | 22 | Participants | |
| University of Michigan Sedation Scale | Midazolam | Unsatisfactory sedation on transfer to OR table | 25 | Participants | |
| University of Michigan Sedation Scale | Dexmedetomidine | Unsatisfactory sedation on transfer to OR table | 14 | Participants | |
| Acceptance of Mask Induction | Midazolam | Satisfactory mask induction | 35 | Participants | |
| Acceptance of Mask Induction | Dexmedetomidine | Satisfactory mask induction | 29 | Participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Midazolam | 38 | |
| Overall Study | STARTED | Dexmedetomidine | 37 | |
| Overall Study | COMPLETED | Midazolam | 37 | |
| Overall Study | COMPLETED | Dexmedetomidine | 36 | |
| Overall Study | NOT COMPLETED | Midazolam | 1 | |
| Overall Study | NOT COMPLETED | Dexmedetomidine | 1 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Midazolam | ||
| Total, all-cause mortality | Dexmedetomidine | ||
| Total, other adverse events | Midazolam | 0 | 37 |
| Total, other adverse events | Dexmedetomidine | 0 | 36 |
| Total, serious adverse events | Midazolam | 0 | 37 |
| Total, serious adverse events | Dexmedetomidine | 0 | 36 |
Source ClinicalTrials.gov
Papers10
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Midazolam vs Dexmedetomidine: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02250703
GET https://conductscience.org/api/trials/v1/NCT02250703/registered