Trial reportBMC pediatrics2014
Utility of intranasal Ketamine and Midazolam to perform gastric aspirates in children: a double-blind, placebo controlled, randomized study.
Trial report in BMC pediatrics, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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.
Who cites it
11 citing papers in PubMed, 1 synthesis or guideline pooled it, 30 citations in OpenAlex.
- Intranasal ketamine for procedural sedation and analgesia in children: A systematic review.PloS one · 2017Pooled it
- Comparison of combined intranasal dexmedetomidine and ketamine versus chloral hydrate for pediatric procedural sedation: a randomized controlled trial.Korean journal of anesthesiology · 2025Trial
- Trial
- Trial
- Does sevoflurane add to outpatient procedural sedation in children? A randomised clinical trial.BMC pediatrics · 2017Trial
- The nose has it: Opportunities and challenges for intranasal drug administration for neurologic conditions including seizure clusters.Epilepsy & behavior reports · 2023Review
- A Pilot Study Testing Intranasal Ketamine for the Treatment of Procedural Anxiety in Children Undergoing Laceration Repair.Journal of child & adolescent trauma · 2022Article
- In Vitro Evaluation of Nasal Aerosol Depositions: An Insight for Direct Nose to Brain Drug Delivery.Pharmaceutics · 2021Review
- Comparison of desflurane and sevoflurane on postoperative recovery quality after tonsillectomy and adenoidectomy in children.Experimental and therapeutic medicine · 2019Article
- Non-Parenteral Medications for Procedural Sedation in Children- A Narrative: Review Article.Iranian journal of child neurology · 2015Review
- Availability and utilization of opioids for pain management: global issues.Ochsner journal · 2014Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundWe performed a prospective, randomized, placebo-controlled study aimed to evaluate the efficacy and safety of a sedation protocol based on intranasal Ketamine and Midazolam (INKM) administered by a mucosal atomizer device in uncooperative children undergoing gastric aspirates for suspected tuberculosis. PRIMARY OUTCOME: evaluation of Modified Objective Pain Score (MOPS) reduction in children undergoing INKM compared to the placebo group. SECONDARY OUTCOMES: evaluation of safety of INKM protocol, start time sedation effect, duration of sedation and evaluation of parents and doctors' satisfaction about the procedure.
methodsIn the sedation group, 19 children, mean age 41.5 months, received intranasal Midazolam (0.5 mg/kg) and Ketamine (2 mg/kg). In the placebo group, 17 children received normal saline solution twice in each nostril. The child's degree of sedation was scored using the MOPS. A questionnaire was designed to evaluate the parents' and doctors' opinions on the procedures of both groups.
resultsFifty-seven gastric washings were performed in the sedation-group, while in the placebo-group we performed 51 gastric aspirates. The degree of sedation achieved by INMK enabled all procedures to be completed without additional drugs. The mean duration of sedation was 71.5 min. Mean MOPS was 3.5 (range 1-8) in the sedation-group, 7.2 (range 4-9) in the placebo-group (p <0.0001). The questionnaire revealed high levels of satisfaction by both doctors and parents in the sedation-group compared to the placebo-group. The only side effect registered was post-sedation agitation in 6 procedures in the sedation group (10.5%).
conclusionsOur experience suggests that atomized INKM makes gastric aspirates more acceptable and easy to perform in children.
trial registrationUnique trial Number: UMIN000010623; Receipt Number: R000012422.
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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.