Sub-Anaesthetic Ketamine at C-Section to Prevent Postpartum Depression: Double-Blind RCT (Alipoor / Sarkoohi, Rafsanjan Iran 2021)
Double-blind, randomised clinical trial of sub-anaesthetic ketamine vs placebo administered at the time of elective caesarean section for prevention of postpartum depression (J Med Life 2021 Jan-Mar; Alipoor M, Loripoor M, Kazemi M, Farahbakhsh F, Sarkoohi A; Rafsanjan University of Medical Sciences, Iran; PMID 33767791; DOI 10.25122/jml-2020-0116). Participants: pregnant women aged 18–35, elective C-section, ASA class 1/2, low-risk pregnancy, no history of underlying disease or drug abuse. Exclusions: post-delivery haemorrhage requiring transfusion, withdrawal of consent. n=67 analysed (sample size calculation originally ~35/arm). Intervention: ketamine IV (sub-anaesthetic dose) at induction vs saline placebo. Primary outcome: postpartum depression assessed by standardised scale (EPDS or HDRS) at postpartum follow-up. No CT.gov registration; no DataBankList; no IRCT number found in abstract text. Iranian clinical trial registries (IRCT) not searchable via CT.gov.
Study Arms & Interventions
Intervention group
experimentalReceives Nesdonal and ketamine during the induction of anesthesia
Interventions
- Placebo1.5 mg/kgvia IV• single dose• 1 doses total
Dose range 1-2 mg/kg
- Ketamine0.5 mg/kgvia IV• single dose• 1 doses total
Administered during induction of anesthesia
Control group
active comparatorReceives only Nesdonal during the induction of anesthesia
Interventions
- Placebo4 mg/kgvia IV• single dose• 1 doses total
Dose range 3-5 mg/kg
Primary Results(1 publication)
Participants
Adverse Events (from all publications)
| Arm / Group | n | Any TEAE | Severe | Serious | Discont. |
|---|---|---|---|---|---|
| Intervention groupexperimental | 67 | — | — | — | — |
| Control groupactive_comparator | 67 | — | — | — | — |
* No treatment-emergent adverse events (TEAEs) or other safety outcomes for the mothers were reported in the paper. The paper discusses Apgar scores for neonates, but these are not maternal safety outcomes.