Evidence map›Paper›PMID 15675259›Full record

Trial reportAnesthesia progress2004

Intranasal sufentanil/midazolam versus ketamine/midazolam for analgesia/sedation in the pediatric population prior to undergoing multiple dental extractions under general anesthesia: a prospective, double-blind, randomized comparison.

J A Roelofse, E A Shipton, C J de la Harpe, R J Blignaut

Registry-linked trialOpen access · greenAbstract readClinical TrialRandomized Controlled Trial
In one paragraph

Trial report in Anesthesia progress, 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03043430 (Anxiolysis for Emergency Department Procedures in Pediatric Patients Using Intranasal Ketamine Compared With Intranasal Midazolam), which is not on this map. Cited by 21 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 2 pooled it
0.9field-weighted citation impact, top 26% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03043430 phase4terminatednot on this mapstarted 2016, after this paper: background citation

Anxiolysis for Emergency Department Procedures in Pediatric Patients Using Intranasal Ketamine Compared With Intranasal Midazolam: A Randomized Controlled Trial

TypeinterventionalSponsorBrooke Army Medical CenterRan2016 to 2023Enrolled10ConditionsAnxiety, Pediatric ALL, Procedural AnxietyArmsKetamine 100 MG/ML, Midazolam 5 MG/ML
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 2 syntheses or guidelines pooled it, 67 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Article
  7. Article
  8. Advantages of ketamine in pediatric anesthesia.Open medicine (Warsaw, Poland) · 2022
    Review
  9. Article
  10. Article
  11. Article
  12. Article
  13. Review
  14. Dexmedetomidine Supported Office Based Genioplasty: A Pilot Study.Journal of maxillofacial and oral surgery · 2015
    Article
  15. Article
  16. Review
  17. Article
  18. Translational research in central nervous system drug discovery.NeuroRx : the journal of the American Society for Experimental NeuroTherapeutics · 2005
    Review
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

4 authors at 1 institution in 1 country.

J A RoelofseDepartment of Anesthesiology, Faculty of Dentistry, University of Stellenbosch.
E A Shipton
C J de la Harpe
R J Blignaut
Stellenbosch University · ZA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This article details a double-blind, randomized study evaluating the efficacy and safety of intranasal sufentanil and intranasal midazolam (S/M) when compared with intranasal ketamine and intranasal midazolam (K/M) for sedation and analgesia in pediatric patients undergoing dental surgery. Fifty healthy ASA status 1 children aged 5-7 years, weighing 15-20 kg, and having 6 or more teeth extracted, were randomly allocated to 2 groups of 25 patients each (n = 50). In the S/M group, 25 children received intranasal sufentanil 20 microg, and intranasal midazolam 0.3 mg/kg 20 minutes before the induction of anesthesia. In the K/M group, 25 children received intranasal ketamine 5 mg/kg and intranasal midazolam 0.3 mg/kg 20 minutes before the induction of anesthesia. Sevoflurane in nitrous oxide and oxygen was used for induction and maintenance of anesthesia. This study demonstrated the safety and efficacy of both methods with ease of administration, combined with a rapid onset of action. Both groups were equally sedated. A smooth mask induction of anesthesia was experienced in the majority of children. Effective postoperative analgesia for multiple dental extractions was provided. The intranasal administration of drugs for sedation and analgesia has some promising features in preschool children undergoing multiple dental extractions.

Indexed as

Administration, IntranasalAnalgesicsAnesthesia, DentalAnesthesia, GeneralAnesthetics, CombinedAnesthetics, InhalationChildChild, PreschoolDouble-Blind MethodFemaleHumansHypnotics and SedativesKetamineMaleMethyl EthersMidazolamAnalgesicsAnesthetics, CombinedAnesthetics, InhalationHypnotics and SedativesKetamineMethyl EthersMidazolamNitrous OxideSevofluraneSufentanil

Identifiers

PMID15675259
PMCPMC2007493
OpenAlexW1551279503

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.