Phase 2
N=8
Ketamine to Improve Recovery After Cesarean Delivery - Part 1
Obstetric Pain · Postpartum Depression · Breastfeeding · Pain, Acute · Pain, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT04037085 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcome: Primary: Ketamine (AUC) — 28.46 mcg*min/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ketamine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Grace Lim, MD, MS
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ketamine (AUC) |
28.46 | — |
| PRIMARY Steady State (Css) |
35.58 | — |
| PRIMARY Elimination Half Life (T1/2) for Ketamine |
364 | — |
| PRIMARY Volume of Distribution Steady State (Vdss) |
1076 | — |
| PRIMARY Ketamine Milk to Plasma Ratio (M:P) |
3.15 | — |
| PRIMARY Nor-ketamine Milk to Plasma Ratio |
1.5 | — |
| PRIMARY Hydroxynorketamine M:P Ratio |
0.06 | — |
| PRIMARY Relative Infant Dose of Ketamine (RID KET) |
0.0152 | — |
| PRIMARY Relative Infant Dose of Ketamine Equivalent (Ketamine, Norketamine, Dehydro-norketamine) |
0.0217 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04037085). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.