A Phase 4 interventional study of Ketamine and Placebo in Non Elective Cesarean Section and Ketamine Analgesia, sponsored by B.P. Koirala Institute of Health Sciences. Completed at 1 site in Nepal. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2019-08-20.
Sponsored by B.P. Koirala Institute of Health Sciences · Phase 4, Interventional, and Treatment
This randomized double blind study will be conducted in pregnant woman planned for non elective cesarean section under spinal anesthesia. Ketamine group will receive intravenous 0.25 mg/kg and placebo group will receive same amount of normal saline after spinal anesthesia prior to skin incision. Postoperative outcomes measures are total opioid consumption and pain scores for 24 hrs.
All women at term(>or =37 weeks of gestation)
Exclusion Criteria:
Women with American society of anesthesiologist physical status>2
the experimental group will receive ketamine intravenously at 0.25 mg per kg before skin incision.
Drug: Ketamine
they will receive same volume of 0.9% normal saline as calculated for experimental group before skin incision.
Drug: Placebo
the analgesic affects of ketamine will be compared between the experimental and placebo group.
Also known as: ketamine hydrochloride
the analgesic requirement will be calculated in placebo group.
Total opioid requirement postoperatively
Total opioid required up to 24 postoperatively in ketamine and placebo group.
Time frame: 24 hrs
Postoperative numerator rating scores(NRS)up to 24 hrs . postoperative )
• Postoperative NRS Scores (on arrival to Post operative care unit), 2, 4, 6, 8, 12 and 24 h ).The NRS ranges from 0- 10 and 0 refers to no pain and 10 means extreme possible pain perceived.
Time frame: 24 hrs
Time to first perception of pain
Time to first perception of pain
Time frame: 24 hrs
Incidence of side effects
Incidence of post operative nausea and vomiting, shivering, sedation scores, side effects related to ketamine during the first 24h
Time frame: 24 hrs
Plan to share: No
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
B.P. Koirala Institute of Health Sciences