Last reviewed · How we verify
NCT05925283
Clinical Study of Oral Midazolam Combined With Esketamine Administered Intranasally for Pediatric Preoperative Sedation
Phase 4 trial testing Midazolam in Anxiety in 126 participants. Status unknown.
30 November 2023
Quick facts
| Lead sponsor | Second Affiliated Hospital of Wenzhou Medical University |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 126 |
| Start date | 30 June 2023 |
| Primary completion | 30 November 2023 |
| Estimated completion | 30 March 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- Midazolam (midazolam) — full drug profile →
- Esketamine (ESKETAMINE) — full drug profile →
- midazolam and esketamine — full drug profile →
Conditions studied
- Anxiety — all drugs for Anxiety →
Sponsor
Second Affiliated Hospital of Wenzhou Medical University
Who can join
Adults 2 to 6, any sex, with Anxiety. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Children are prone to anxiety and even fear before surgery, and such adverse emotions may not only lead to poor induction of anesthesia, but also increase the incidence of postoperative agitation and even lead to postoperative behavioral changes in children. There are many ways to relieve pediatric anxiety, including preoperative medication, games, and cartoons. Preoperative medication is the most commonly used method to relieve pediatric anxiety.The most commonly used pediatric preoperative sedation drugs are midazolam and esketamine.However, oral midazolam may not produce a sedative effect in 20-40% of patients. A good preoperative anxiety-reducing effect was seen in only 60-80% of cases.Therefore, this trial investigates whether the intranasal combination of esketamine with oral midazolam can produce better results than each of the two drugs alone. This will provide a reference for the selection of safe, reliable and appropriate preoperative sedation methods for pediatric patients and provide evidence-based support for comfort care.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05925283
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Midazolam
Trials testing the same drug.
- NCT05945147 — Ketamine and Midazolam Infusions for CRPS: Feasibility Study · Phase 2 · withdrawn
- NCT07525544 — A Study to Investigate the Safety and PK of VH4770359 in Healthy Participants · Phase 1 · not yet recruiting
- NCT07426757 — An Open-Label Study to Evaluate PF-07994525 in Participants With Advanced Cancers · Phase 1 · not yet recruiting
- NCT07435194 — A Clinical Trial in Healthy Participants to Learn How Itraconazole Affects MK-2828 Levels and How MK-2828 Affects Midazo · Phase 1 · recruiting
- NCT07443254 — Prospective IR-led Sedation Feasibility · Phase 1, PHASE2 · recruiting
Other recruiting trials for Anxiety
Currently open trials in the same condition.
- NCT07336238 — Group Retreat Psilocybin Therapy for the Treatment of Anxiety and Depression in Patients With Metastatic Solid Tumors or · Phase 2 · recruiting
- NCT07522944 — AI-Guided Relaxation for Hemodialysis Anxiety · NA · recruiting
- NCT07466875 — Auricular Stimulation for Nicotine Withdrawal in Psychiatric Inpatients · NA · recruiting
- NCT07425951 — Building Cognitive Behavioural Skills With StoryBooks to Reduce Emotional Difficulties in Kindergarten Years · NA · recruiting
- NCT07473505 — Integrative Bilateral Cervical Sympathetic Blocks for Trauma-Related Symptoms in Special Operations Veterans: A Prospect · recruiting
Other Second Affiliated Hospital of Wenzhou Medical University trials
Trials by the same sponsor.
- NCT07466511 — Effect of Bifidobacterium Breve Supplementation on the Onset and Progression of Idiopathic Scoliosis · NA · not yet recruiting
- NCT07530848 — Perioperative Pharmacokinetics of Anesthetic Drugs and Complications in Overweight and Obese Patients · not yet recruiting
- NCT07346443 — Mechanism Study of G Protein-coupled Receptor 81 in Multiple Organ Dysfunction of Heat Stroke · not yet recruiting
- NCT07353970 — Mechanisms of Prognostic Regulation andPrecision Phenotype Ldentification in Severe Infections Driven by SpecializedPro- · not yet recruiting
- NCT07332793 — Mechanisms of Precise Immune Cell Phenotyping and Prognostic Prediction in Severe Infection · not yet recruiting
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 NCT05925283 (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 Second Affiliated Hospital of Wenzhou Medical University
- Last refreshed: 29 June 2023
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/NCT05925283.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing