Trial · NCT01549002
Efficacy of Intranasal Fentanyl at Reducing Pain During Abscess Incision and Drainage (I&D) in Children
NCT01549002, Phase 3, Completed, Columbia University; results first posted 2015-08-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy of Intranasal Fentanyl at Reducing Pain During Abscess Incision and Drainage (I&D) in Children. Trials, record NCT01549002. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01549002
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Intranasal Fentanyl at Reducing Pain During Abscess Incision and Drainage (I&D) in Children
- NCT number
- NCT01549002
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 20 participants, actual
- Lead sponsor
- Columbia University
- Conditions
- Abscess, Pain
- Interventions
- Intranasal Fentanyl, Intravenous Morphine
- First posted
- 2012-03-08
- Last updated
- 2019-04-30
- Results first posted
- 2015-08-21
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Score on the Observational Scale of Behavioral Distress Revised (OSBD-R) | Up to 10 minutes after the procedure completion | Our primary outcome is the Observational Scale of Behavioral Distress - Revised (OSBD-R) to assess observed intra-procedural pain. The total OSBD-R score is a summation of the OSBD-R score of each individual phase. The score in each phase can range from 0 to 23.5. There were four phases in our study, so the range of scores for the total OSBD-R was 0 to 94, with a higher score indicating a greater degree of pain and distress. The four phases in the study are (1) before analgesia administration, (2) ten minutes after analgesia administration but before beginning I\&D, (3) immediately post I\&D procedure (to ascertain the pain perceived during procedure), and (4) ten minutes after procedure completion. The scores documented here are the total OSBD-R scores. |
| Secondary | Score on the Faces Pain Scale Revised (FPS-R) | Up to 10 minutes after procedure completion | The Faces Pain Scale - Revised (FPS-R) is a self-report measure of pain has strong validity and reliability in children 4 - 17 years of age undergoing painful procedures, and will be used to assess patients' self reported pain. A score of 0 means no pain, a score of 10 means very much pain. Therefore, a lower score indicates that a patient is experiencing a lower degree of pain intensity. Patients will complete the FPS-R at four times during their medical encounter: (1) before analgesia administration, (2) ten minutes after analgesia administration but before beginning I\&D, (3) immediately post I\&D procedure (to ascertain the pain perceived during procedure), and (4) ten minutes after procedure completion. |
| Secondary | Number of Patients Satisfied With Analgesia Administered | 10 minutes after procedure completion | Number of patients satisfied with analgesia administered will be evaluated by determining the number of patients who report a Likert scale response of "somewhat satisfied", "very satisfied", or "extremely satisfied" (i.e. any patient who selects any of these three responses will be considered to have been satisfied with analgesia administered). Patients will be asked 10 minutes after procedure completion. If the patient is 8 years of age and older, both the patient and the parent or guardian will complete a satisfaction survey. If the patients is younger than 8 years, their parent or guardian will complete the satisfaction survey. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Score on the Observational Scale of Behavioral Distress Revised (OSBD-R) | Up to 10 minutes after the procedure completion | units on a scale | MEAN | |
| SECONDARY | Score on the Faces Pain Scale Revised (FPS-R) | Up to 10 minutes after procedure completion | (1) before analgesia administration, (2) ten minutes after analgesia administration but before beginning I\&D, (3) immediately post I\&D procedure (to ascertain the pain perceived during procedure), and (4) ten minutes after procedure completion. | units on a scale | MEDIAN |
| SECONDARY | Number of Patients Satisfied With Analgesia Administered | 10 minutes after procedure completion | Patient satisfied with analgesia administered | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Score on the Observational Scale of Behavioral Distress Revised (OSBD-R) | Intranasal Fentanyl | 5.48 | Standard Deviation 4.09 | units on a scale | |
| Score on the Observational Scale of Behavioral Distress Revised (OSBD-R) | Intravenous Morphine | 18.92 | Standard Deviation 14.82 | units on a scale | |
| Score on the Faces Pain Scale Revised (FPS-R) | Intranasal Fentanyl | Before analgesia administration | 6 | Inter-Quartile Range 3.5 to 6.5 | units on a scale |
| Score on the Faces Pain Scale Revised (FPS-R) | Intravenous Morphine | Before analgesia administration | 4 | Inter-Quartile Range 1.5 to 6 | units on a scale |
| Score on the Faces Pain Scale Revised (FPS-R) | Intranasal Fentanyl | 10 min after analgesia, before I&D | 2 | Inter-Quartile Range 1.5 to 4.5 | units on a scale |
| Score on the Faces Pain Scale Revised (FPS-R) | Intravenous Morphine | 10 min after analgesia, before I&D | 4 | Inter-Quartile Range 0 to 6 | units on a scale |
| Score on the Faces Pain Scale Revised (FPS-R) | Intranasal Fentanyl | Immediately post-I&D | 4 | Inter-Quartile Range 0 to 8 | units on a scale |
| Score on the Faces Pain Scale Revised (FPS-R) | Intravenous Morphine | Immediately post-I&D | 10 | Inter-Quartile Range 9.5 to 10 | units on a scale |
| Score on the Faces Pain Scale Revised (FPS-R) | Intranasal Fentanyl | 10 min after procedure completion | 1 | Inter-Quartile Range 0 to 4 | units on a scale |
| Score on the Faces Pain Scale Revised (FPS-R) | Intravenous Morphine | 10 min after procedure completion | 5 | Inter-Quartile Range 2.8 to 6.5 | units on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Intranasal Fentanyl | 10 | |
| Overall Study | STARTED | Intravenous Morphine | 10 | |
| Overall Study | COMPLETED | Intranasal Fentanyl | 10 | |
| Overall Study | COMPLETED | Intravenous Morphine | 6 | |
| Overall Study | NOT COMPLETED | Intranasal Fentanyl | 0 | |
| Overall Study | NOT COMPLETED | Intravenous Morphine | 4 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Oxygen desaturation | Respiratory, thoracic and mediastinal disorders | Intranasal Fentanyl | 0 | 10 | |
| serious | Oxygen desaturation | Respiratory, thoracic and mediastinal disorders | Intravenous Morphine | 1 | 10 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intranasal Fentanyl | ||
| Total, all-cause mortality | Intravenous Morphine | ||
| Total, other adverse events | Intranasal Fentanyl | 0 | 10 |
| Total, other adverse events | Intravenous Morphine | 0 | 10 |
| Total, serious adverse events | Intranasal Fentanyl | 0 | 10 |
| Total, serious adverse events | Intravenous Morphine | 1 | 10 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27387971 | RESULT |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Intranasal Fentanyl vs Intravenous Morphine: Number of Patients Satisfied With Analgesia Administered | Trial comparisons |
| Intranasal Fentanyl vs Intravenous Morphine: serious adverse events | 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/NCT01549002
GET https://conductscience.org/api/trials/v1/NCT01549002/registered