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Pain monitor slashes morphine use in Kids' spine surgery

NCT ID NCT04047225

Symptom relief Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a device called ANI that measures pain during surgery in children having scoliosis correction. The goal was to see if using this monitor to guide pain medicine during surgery would lower the amount of morphine needed in the first 24 hours after surgery. The study involved 260 children under 18 years old.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

260 people

The number who actually took part.

Started

Oct 2020

Finished

Dec 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

10 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age \< 18 years at time of surgery; * Surgical correction of idiopathic scoliosis with or without thoracoplasty; * Weight ≥ 30 kg : in order to allow using target plasma concentration administration of the opioid (remifentanil) and anaesthetic (propofol) agents; (pharmacokinetics models are not validated under this weight) during the intraoperative period; * ASA (American Society of Anesthesiologist) status I to III * Affiliation to the French national health insurance Exclusion Criteria: * Second time of a scoliosis correction in the preceding year (apart the use of halo-gravity traction or non-painful procedures such as digestive endoscopy); * Chronic treatment (\> 3 months) with: opioid agents, anti-epileptic agents or anti-depressant agents; * Bad French language understanding; * Expected difficulties in self-managing pain using the patient-controlled analgesia devices; * ASA (American Society of Anesthesiologist) status IV or V; * Any contraindication to one of the compound of the study: propofol, remifentanil, atracurium, paracetamol, Non-steroidal anti-inflammatory agents. * Patients with a heart pace-maker device * Patient under anti-arrythmic treatment

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Conditions

The condition(s) this trial relates to.

idiopathic scoliosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Scoliosis idiopathic

Contacts and locations

Locations

  • Department of Anesthesiology, Robert Debre University Hospital

    Paris, 75019, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.