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NCT01669642 · ClinicalTrials.gov registry record · NA

Study to Find the Dose of Rapidly Administered Ketamine for Brief Painful Procedures in Children

A NA study, sponsored by Washington University School of Medicine.

Completed
Registry status
NA
Development phase
111
Enrollment target

NCT01669642: Completed NA study, sponsored by Washington University School of Medicine.

NCT01669642 is a NA study that has completed, run by Washington University School of Medicine. The registered enrollment target is 111 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01669642, a NA study, has completed, sponsored by Washington University School of Medicine.

COMPLETED
Registry status
NA
Development phase
111 participants
Enrollment target

Study Summary

The purpose of the study is to find the dose of rapidly administered ketamine in 3 different pediatric age groups (2-5, 6-11 and 12-17) for abscess drainage and fracture reduction. Ketamine is the most common drug administered to children to facilitate painful procedures in the emergency setting because it achieves potent sedation, pain relief and amnesia with minimal adverse cardiopulmonary effects.(1-5) However, the 1-2 hour recovery period (1,6) associated with standard ketamine administration guidelines(7) strains work flow because it requires bedside one-on-one nurse monitoring in a treatment room, tying up these limited and valuable resources. Consequently, a combination of two other drugs, propofol + fentanyl (P/F), with recovery of 20-30 minutes, is rapidly gaining popularity for procedural sedation despite more frequent respiratory depression, apnea and hypotension caused by this technique.(2,4,8,9) The investigators believe recovery associated with our novel method for administering ketamine is significantly shorter than with the standard larger dose more slowly administered ketamine technique(7). Through the investigators clinical experience, the investigators have found rapid infusion of smaller than standard doses of ketamine safely achieves the drug's sedative effect, with the benefit of more rapid recovery due to the use of a smaller dose. However, this novel technique challenges published beliefs that time of recovery from ketamine sedation does not differ significantly with the dose administered, within the usual dose ranges, and that rapid infusion may cause respiratory depression, similar to that seen with other classes of sedative-analgesic drugs.(7,10) the investigators believe the slow infusion recommended by standard guidelines(7) requires a larger ketamine dose necessary to achieve effective sedation, and, consequently, prolongs recovery. It is the prolonged recovery that has prompted increased use of other less safe but briefer sedatives,

Primary Outcome

ED50 is the dose of rapidly administered ketamine that achieves effective sedation in 50% of patients. ED95 is the dose of ketamine that can provide effective sedation in 95% of children undergoing abscess drainage or fracture reduction. ED95 will be calculated for the 3 age groups (2-5, 6-11 and 12-17) independently for both the procedures: abscess drainage and fracture reduction.

Interventions

  • DRUG Ketamine

Trial Details

FieldValue
Enrollment Target 111 participants
Start Date 2012-04
Est. Completion 2014-08
Phase NA

What the finished NCT01669642 record still lists

NCT01669642 is an interventional study that assigns participants to a tested intervention. The registered 111 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 1 intervention - of which Ketamine is the first listed.

NCT01669642 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01669642 about?

NCT01669642 is a clinical study titled "Study to Find the Dose of Rapidly Administered Ketamine for Brief Painful Procedures in Children". The purpose of the study is to find the dose of rapidly administered ketamine in 3 different pediatric age groups (2-5, 6-11 and 12-17) for abscess drainage and fracture reduction. Ketamine is the most common drug administered to children to facilitate painful procedures in the emergency setting be...

What is the current status of trial NCT01669642?

This trial is currently completed. It is a NA study. The enrollment target is 111 participants. The study started on 2012-04. Estimated completion is 2014-08.

What interventions are being tested in trial NCT01669642?

The interventions under investigation include: Ketamine (DRUG).

Who is sponsoring clinical trial NCT01669642?

This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01669642's enrollment target sits among peer trials

111 816th of 2000 higher than 1,185 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01669642, the US trial registry maintained by the National Library of Medicine. NCT01669642 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.