Ketamine-propofol Versus Ketamine Alone for Procedural Sedation in Adults

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

1 site in 1 country.

About this study

Official title: Ketamine-propofol Versus Ketamine Alone for Procedural Sedation in Adults : a Blinded, Randomized Controlled Trial

Conditions

Fracture, Dislocation

Being tested

Procedural sedation with ketamine-propofol combination, Procedural sedation with ketamine alone

Keywords

Procedural sedation, Ketamine-propofol, Ketamine

Medical subject headings

Fractures, Bone, Joint Dislocations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Procedural sedation with ketamine-propofol combinationDrug

  K= Kétamine P= Propofol RSS= Ramsay Sedation Score

  At t0: 0.5 mg/kg of K (0.1 ml/kg of 5 mg/ml K) followed by 0.5 mg/k of P (0.1 ml/kg of 5 mg/ml P).

  At t0 + 4 min, if needed to obtain an optimal sedation (RSS of 4 or 5): 0.25 mg/kg of K (0.05 ml/kg of 5 mg/ml K) followed by 0.25 mg/kg of P (0.05 ml/kg of 5 mg/ml P).

  At t0 + 8 min, if needed to obtain an optimal sedation (RSS of 4 or 5): 0.25 mg/kg of K (0.05 ml/kg of 5 mg/ml K) followed by 0.25 mg/kg of P (0.05 ml/kg of 5 mg/ml P).

  At t0 + 12 min, if maximal doses have been reached (1 mg/kg of K + 1 mg/kg of P) but the optimal sedation has not been obtained, the procedural sedation will be recorded as a failure in the analysis, and the patient will receive another procedural sedation product (at the discretion of the caregiver).

• Procedural sedation with ketamine aloneDrug

  K= Ketamine I= Intralipid placebo

  At t0: 1 mg/kg of K (0.1 ml/kg of 10 mg/ml K), followed by 0.1 ml/kg of I (physical placebo of propofol in the other arm).

  At t0 + 4 min, if needed to obtain an optimal sedation (Ramsay Sedation Score of 4 or 5): 0.5 mg/kg of K (0.05 ml/kg of 10 mg/ml K), followed by 0.05 ml/kg of I.

  At t0 + 8 min, if needed to obtain an optimal sedation (Ramsay Sedation Score of 4 or 5): 0.5 mg/kg of K (0.05 ml/kg of 10 mg/ml K), followed by 0.05 ml/kg of I.

  At t0 + 12 min, if maximal doses have been used (2 mg/kg of K) but the optimal sedation has not been obtained, the procedural sedation will be recorded as a failure in the analysis, and the patient will receive another procedural sedation product (at the discretion of the caregiver).

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Proportion of recovery agitation

   Patient will be followed during the procedural sedation, for an average time of thirty minutes after the first injection

   Measured: Recovery agitation is noted after procedural sedation for each patient (30 minutes)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted6 Mar 2012 (estimated)
2. Study startApr 2012
3. Primary completionJan 2016
4. Study completionJan 2016

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (1)Papers the sponsor has linked to this study.
• Other trials for FractureStudies of the same condition, open and under way.
• More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.