Evidence map›Paper›PMID 39006192›Full record

Trial reportDrug design, development and therapy2024

Nalbuphine in Pediatric Emergence Agitation Following Cochlear Implantation: A Randomized Trial.

Yan Li, Qi Li, Guangchao Zhao, Haopeng Zhang, Haixing Zhong, Yi Zeng

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Drug design, development and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Yan LiDepartment of Anesthesia and Perioperative Medicine, Xijing Hospital, the Fourth Military Medical University, Xi'an, 710000, People's Republic of China.
Qi LiDepartment of Anesthesia and Perioperative Medicine, Xijing Hospital, the Fourth Military Medical University, Xi'an, 710000, People's Republic of China.
Guangchao ZhaoDepartment of Anesthesia and Perioperative Medicine, Xijing Hospital, the Fourth Military Medical University, Xi'an, 710000, People's Republic of China.
Haopeng ZhangDepartment of Anesthesia and Perioperative Medicine, Xijing Hospital, the Fourth Military Medical University, Xi'an, 710000, People's Republic of China.
Haixing ZhongDepartment of Anesthesia and Perioperative Medicine, Xijing Hospital, the Fourth Military Medical University, Xi'an, 710000, People's Republic of China.
Yi ZengDepartment of Anesthesia and Perioperative Medicine, Xijing Hospital, the Fourth Military Medical University, Xi'an, 710000, People's Republic of China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: To investigate the effects of nalbuphine on emergency agitation (EA), which affects up to 80% of the children following otolaryngology procedures, in children undergoing cochlear implantation. Methods: A prospective double-blinded randomized controlled clinical trial was conducted between November 2020 and October 2022. Eligible children, aged 6 months to 3 years old, were randomly assigned to either 0.1 mg/kg, 0.15 mg/kg, 0.2 mg/kg nalbuphine or 0.9% saline groups. EA was defined by the Pediatric Anesthesia Emergence Delirium (PAED) score ≥10. Extubation time, post-anesthesia care unit (PACU) length of stay, severe EA (PAED ≥ 15), peak PAED score, the Faces, Legs, Activity, Cry, and Consolability (FLACC) scale, Ramsay sedation score, and adverse events were also recorded. Results: A total of 104 children were enrolled, with 26 children in each group. Nalbuphine significantly reduced the EA occurrence from 73.1% in the saline group to 38.5%, 30.8%, and 26.9% in the 0.1 mg/kg, 0.15 mg/kg, and 0.2 mg/kg nalbuphine groups, respectively ( Conclusion: Young children undergoing cochlear implantation surgery were at a high risk of EA and postoperative pain, while 0.2 mg/kg nalbuphine might be an ideal candidate for EA and pain prevention when used under close monitoring. Trial Registration: ChiCTR2000040407.

Indexed as

Analgesics, OpioidCochlear ImplantationEmergence DeliriumNalbuphineChild, PreschoolDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansInfantMaleProspective StudiesPsychomotor AgitationAnalgesics, OpioidNalbuphinecochlear implantationemergence agitationnalbuphinepostoperative pain

Identifiers

PMID39006192
PMCPMC11244056

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Registered trials

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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.