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NCT01971853: Analgesia
Does Preventive Analgesia Improve the Outcome of Demerol-Vistaril Procedural Sedations in Pediatric Dentistry?
NA trial testing oral placebo in Pain in 88 participants. Terminated before completion.
31 December 2016
Quick facts
| Lead sponsor | University of Colorado, Denver |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 88 |
| Start date | 1 October 2013 |
| Primary completion | 31 December 2016 |
| Estimated completion | 31 December 2016 |
| Sites | 1 location across United States |
Drugs / interventions tested
- oral placebo
- Oral Analgesics
Conditions studied
- Pain — all drugs for Pain →
Sponsor
University of Colorado, Denver
Who can join
Adults 2 to 8, any sex, with Pain. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Improved Sedation Effectiveness Based on Numerical Value for Effectiveness as Noted in Description
Time frame: 60 minutes treatment started
A Sedation effectiveness evaluation criteria chart will be utilized to determine a numerical value for the effectiveness as follows: 1 = Effective/Excellent; 2 = Partially effective/good; 3 = Ineffective/fair; 4 = Aborted/Poor
Sponsor's own description
All healthcare providers strive continually to improve the outcome of their treatment approaches. The investigators hypothesize that preventive analgesics administered before a child is sedated with a Demerol-Vistaril regimen will improve the outcome of a sedation.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Ibuprofen for acute postoperative pain in children.
Pessano S, Gloeck NR, Tancredi L, Ringsten M, et al · · 2024 · cited 7× · PMID 38180091 · DOI 10.1002/14651858.cd015432.pub2
Verify or expand the search:
- PubMed search for NCT01971853
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University of Colorado, Denver trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01971853 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Colorado, Denver
- Last refreshed: 28 December 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01971853.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing