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CompletedPhase 2Results posted

Ketamine to Improve Recovery After Cesarean Delivery - Part 1

NCT04037085 · KINETIC · Grace Lim, MD, MS

Closed to entry
Status
Not accepting participants
Phase 2
Phase
8
Target enrolment
2
Study sites
1 US states

What it is testing

Summary

The objective of this study is evaluate the breastmilk transfer and pharmacokinetics (Part 1) and effectiveness (Part 2) of a post-cesarean delivery intravenous ketamine bolus-and-infusion strategy, as a preventive analgesic modality to reduce pain and opioid requirements. In Part 1, physiochemical analysis of pharmacokinetic/pharmacodynamic (PK/PD) and breastmilk transfer of ketamine and its metabolites will be assessed. Additionally calculated estimations for neonatal and infant exposure will be assessed. In Part 2, PK/PD assessments will continue in a larger cohort; endpoints will also include postpartum pain, depression scores, central sensitization measures, patient-reported postpartum recovery scores, breastfeeding, and parent-infant bonding, assessed in the acute post-cesarean period and up to 12 weeks postpartum in a randomized controlled trial.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Ketamine (AUC)

    Measured over 12 hour ketamine infusion

  • Steady State (Css)

    Measured over 12 hours after ketamine infusion start

  • Elimination Half Life (T1/2) for Ketamine

    Measured over 27 hours postpartum or 24 hour CTRC appointment for weaning population

  • Volume of Distribution Steady State (Vdss)

    Measured over 27 hours postpartum or 24 hour CTRC appointment for weaning population

  • Ketamine Milk to Plasma Ratio (M:P)

    Measured over 27 hours postpartum or 24 hour CTRC appointment for weaning population

  • Nor-ketamine Milk to Plasma Ratio

    Measured over 27 hours postpartum or 24 hour CTRC appointment for weaning population

  • Hydroxynorketamine M:P Ratio

    Measured over 27 hours postpartum or 24 hour CTRC appointment for weaning population

  • Relative Infant Dose of Ketamine (RID KET)

    Measured over 27 hours postpartum or 24 hour CTRC appointment for weaning population

  • Relative Infant Dose of Ketamine Equivalent (Ketamine, Norketamine, Dehydro-norketamine)

    Measured over 27 hours postpartum or 24 hour CTRC appointment for weaning population

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 99 Years
Ages
FEMALE
Sex
Accepted
Healthy volunteers
Inclusion Criteria: * Adult female patients (i.e., ≥18 years of age) and able to provide informed consent * Cesarean Delivery, Scheduled or Non-Emergent (delivery within 15 minutes not necessary), or female weaning off of breastfeeding * Cesarean cohort: ASA PS 2 or 3, with or without E designation (delivery within 15 minutes not necessary), Scheduled or Non-Emergent * Spinal anesthesia with intrathecal morphine if Cesarean Delivery, Scheduled or Non-Emergent * Multimodal postop analgesia with IV ketorolac, PO NSAID, and PO APAP if Cesarean Delivery, Scheduled or Non-Emergent * Women who do not plan to breastfeed or who want to temporarily withhold breastfeeding or who are weaning off of breastfeeding (Part 1) Exclusion Criteria: * Cesarean Delivery under General Anesthesia * Allergies to study medications * ASA PS 4 or 4E * ASA PS with E designation because delivery within 15 minutes required * ASA PS greater than 4 (moribund patients) * Contraindications to spinal anesthesia * Contraindications to NSAIDs (gastric bypass, etc.) * Contraindication to any other multimodal analgesia medicine * Significant psychiatric history (depression and anxiety NOT exclusion criteria), uncontrolled hyperthyroidism, cardiac disease, fever, hypertension * Adverse occurrence during caesarean section such as hemorrhage, need for transfusion, hemodynamic instability * Placenta accreta spectrum or previa with large anticipated blood loss * History of hallucinations, alcohol or illicit substance use/abuse, chronic opioid therapy, or chronic pain (chronic pain - defined by any condition requiring consistent follow up with pain specialist or daily administration of pain medications that could augment sedative effects) * Pre-eclampsia with severe features

Where

2 study sites

FacilityCityRegionCountry
UPMC Montefiore Hospital CTRCPittsburghPennsylvaniaUnited States
Minhnoi C Wroble BiglanPittsburghPennsylvaniaUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT04037085 on ClinicalTrials.gov →

Last updated in the registry 2022-12-20. Registry records change; this page reflects the data build of 2026-08-25.

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Where this trial sits

Substance

Recruiting in

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