Single Bolus Low-Dose Ketamine for Prevention of Postpartum Depression After Caesarean Section: A Randomized, Double-Blind, Placebo-Controlled Trial
Prospective double-blind placebo-controlled RCT (Shenzhen Maternity and Child Healthcare Hospital) testing whether a single intra-operative bolus of ketamine 0.25 mg/kg IV (vs 0.9% saline) after umbilical cord clamping during elective caesarean section reduces postpartum depression. Enrolled: 330 ASA I–II parturients (screened 448, analysed 325). Primary outcome: EPDS at 3 days and 6 weeks postpartum. Secondary: NRS pain. Conducted October 2015 – March 2016.
Study Arms & Interventions
Ketamine
experimentalIntravenous ketamine (0.25 mg/kg diluted to 10 mL with 0.9% saline) administered within 5 min following clamping of the neonatal umbilical cord.
Interventions
- Ketamine0.25 mg/kgvia IV• single dose• 1 doses total
diluted to 10 mL with 0.9% saline
Saline
placeboIntravenous 10 mL of 0.9% saline administered within 5 min following clamping of the neonatal umbilical cord.
Interventions
- Placebovia IV• single dose• 1 doses total
10 mL of 0.9% saline
Primary Results(1 publication)
Participants
Adverse Events (from all publications)
| Arm / Group | n | Any TEAE | Severe | Serious | Discont. |
|---|---|---|---|---|---|
| Ketamineexperimental | 162 | — | — | — | — |
| Salineplacebo | 163 | — | — | — | — |
* Specific adverse events reported in Table 3 include vomiting, headache, hallucination, dizziness, drowsiness, diplopia, and Ramsay sedation score >3. Counts for these individual events are provided in Table 3 but a summary 'any TEAE' count is not.