Clinical trial · Interventional
Intranasal Versus Intravenous Drug in Painful Procedure for Outpatient Oncologic Participants
Intranasal Dexmedetomidine and Fentanyl Versus Intravenous Midazolam and Ketamine in Sedation for Painful Outpatient Procedures
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Pain is a vital sign that depends on personal experience involving different factors such as previous sensory and emotional experience, age, spiritual and cultural aspects, that makes it harder to evaluate, especially in young children. Pain control is important to diminish the anxiety of the child and family, also this is more important in patients who require procedure and treatment that are more painful, like oncological and hematological patients. The study aims to measure if the intranasal drugs (dexmedetomidine and fentanyl) has the same outcomes when compared with intravenous drug (ketamine and midazolam), but with less side effects. The participants are patients from an oncologic outpatient, that will be submitted to cerebrospinal fluid puncture, myelogram or both will be randomized assigned to both groups. The study will compare physiological variables ( heart rate, respiratory rate and blood pressure) and sedation and pain scales to see if its work properly. The study purpose is to evaluate if intranasal drug works in the same way with less side effects comparing with the usual treatment.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Analgesia | — | UNRESOLVED | — |
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
| Procedural Pain | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| intranasal dexmedetomidine | Drug | — | UNRESOLVED |
| intranasal fentanyl | Drug | — | UNRESOLVED |
| intravenous ketamine (ketalar®) | Drug | — | UNRESOLVED |
| intravenous midazolam | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- intranasal dexmedetomidine and fentanyl
- description
- Dexmedetomidine (precedex®) and fentanyl will be administered by intranasal routes, seeing if both sedative (dexmedetomidine) and analgesic (fentanyl) can give enough sedation for procedure
- interventionNames
- Drug: intranasal dexmedetomidine
- Drug: intranasal fentanyl
- type
- ACTIVE_COMPARATOR
- label
- intravenous ketamine and midazolam
- description
- ketamine (ketalar®) and midazolam intravenous will be using to compare the efficiency of intranasal drugs
- interventionNames
- Drug: intravenous ketamine (ketalar®)
- Drug: intravenous midazolam
Primary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 8 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with oncohematological diseases that requires cerebrospinal fluid, myelogram or both for staging and monitoring their treatment ( leukemia, lymphoma, solid tumors and bone marrow aplasia) * Patients who is undergoing to collect cerebrospinal fluid, myelogram or both; * aged between two and eight years; * absence of tumor recurrence. Exclusion Criteria: * Previous neurologic disease; * Using of opioid previously; * Neurological developmental delay
References
Publications (8)
- BACKGROUNDManworren RC, Stinson J. Pediatric Pain Measurement, Assessment, and Evaluation. Semin Pediatr Neurol. 2016 Aug;23(3):189-200. doi: 10.1016/j.spen.2016.10.001. Epub 2016 Oct 17. PMID 27989326
- BACKGROUNDFantacci C, Fabrizio GC, Ferrara P, Franceschi F, Chiaretti A. Intranasal drug administration for procedural sedation in children admitted to pediatric Emergency Room. Eur Rev Med Pharmacol Sci. 2018 Jan;22(1):217-222. doi: 10.26355/eurrev_201801_14120. PMID 29364490
- BACKGROUNDLi BL, Zhang N, Huang JX, Qiu QQ, Tian H, Ni J, Song XR, Yuen VM, Irwin MG. A comparison of intranasal dexmedetomidine for sedation in children administered either by atomiser or by drops. Anaesthesia. 2016 May;71(5):522-8. doi: 10.1111/anae.13407. Epub 2016 Mar 3. PMID 26936022
- BACKGROUNDTug A, Hanci A, Turk HS, Aybey F, Isil CT, Sayin P, Oba S. Comparison of Two Different Intranasal Doses of Dexmedetomidine in Children for Magnetic Resonance Imaging Sedation. Paediatr Drugs. 2015 Dec;17(6):479-85. doi: 10.1007/s40272-015-0145-1. PMID 26323489
- BACKGROUNDJun JH, Kim KN, Kim JY, Song SM. The effects of intranasal dexmedetomidine premedication in children: a systematic review and meta-analysis. Can J Anaesth. 2017 Sep;64(9):947-961. doi: 10.1007/s12630-017-0917-x. Epub 2017 Jun 21. PMID 28639236
- BACKGROUNDGupta A, Dalvi NP, Tendolkar BA. Comparison between intranasal dexmedetomidine and intranasal midazolam as premedication for brain magnetic resonance imaging in pediatric patients: A prospective randomized double blind trial. J Anaesthesiol Clin Pharmacol. 2017 Apr-Jun;33(2):236-240. doi: 10.4103/joacp.JOACP_204_16. PMID 28781452
- BACKGROUNDChatrath V, Kumar R, Sachdeva U, Thakur M. Intranasal Fentanyl, Midazolam and Dexmedetomidine as Premedication in Pediatric Patients. Anesth Essays Res. 2018 Jul-Sep;12(3):748-753. doi: 10.4103/aer.AER_97_18.