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NCT04526652
Evaluating Stress Response and Anxiety Score in Paediatric Patients
Phase 2 trial testing Dexmedetomidine in Anxiety and Fear in 60 participants. Completed in 1 August 2021.
31 July 2021
Quick facts
| Lead sponsor | Universiti Sains Malaysia |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 60 |
| Start date | 1 December 2020 |
| Primary completion | 31 July 2021 |
| Estimated completion | 1 August 2021 |
| Sites | 1 location across Malaysia |
Drugs / interventions tested
- Dexmedetomidine (dexmedetomidine) — full drug profile →
- Placebo
Conditions studied
- Anxiety and Fear — all drugs for Anxiety and Fear →
- Anesthesia — all drugs for Anesthesia →
Sponsor
Universiti Sains Malaysia — full company profile →
Who can join
Adults 1 to 12, any sex, with Anxiety and Fear or Anesthesia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To date, there have been no studies done relating serum cortisol levels and intranasal dexmedetomidine sedation. However, there was a behavioral study done on pediatric patients confirming reduction serum cortisol levels with perioperative dialogue intervention.There have been a number of studies done on adult patients indicating that dexmedetomidine was indeed capable of reducing level of anxiety with evidence of lower serum cortisol levels. Hence, we postulated that intranasal dexmedetomidine administration in pediatric patients will lower the serum cortisol levels but we need to evaluate the extent of reduction.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04526652
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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Other recruiting trials for Anxiety and Fear
Currently open trials in the same condition.
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- NCT06004115 — Processes and Circuitry Underlying Threat Sensitivity as a Treatment Target for Co-morbid Anxiety and Depression · Phase 4 · recruiting
- NCT03821779 — Prefrontal Oscillations in Social Anxiety Disorder (POSAD) · NA · active not recruiting
Other Universiti Sains Malaysia 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 NCT04526652 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universiti Sains Malaysia
- Last refreshed: 25 October 2021
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/NCT04526652.
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