About this trial
Cesarean delivery is a commonly performed surgical procedure associated with worse postpartum pain when compared to vaginal birth. Uncontrolled postpartum pain is associated with increased neonatal and maternal risks. Multimodal non-opioid pain medications, including acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs) are the preferred first-line therapies. There is no standard practice, however, on best dosing schedules (ie staggered or different time v. simultaneous or same time). This protocol describes a randomized clinical trial aimed to determine whether staggered dosing of acetaminophen and NSAIDs in superior to simultaneous dosing in controlling post-cesarean pain.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
>/= 34 weeks gestation
Singleton pregnancy
Delivery via cesarean section under regional anesthesia
Disqualifiers
Contraindication to acetaminophen or NSAIDs
Current or history of opioid use or misuse
Intrauterine fetal demise
Major congenital anomaly
Trial design
Parallel
Treatments tested in this trial
Acetaminophen
DrugAcetaminophen 1000 mg q6H
NSAID (Ketorolac/Ibuprofen)
DrugNSAID (ketorolac 30 mg q6H for first 24 hours post-op followed by ibuprofen 600 mg q6H)
Treatment groups
Trial outcomes
Primary outcomes
Postpartum pain control
Visual analog pain score (VAS) with movement. Scale ranges from 0-10 with 0 indicating no pain and 10 indicating worst possible pain
Opioid consumption
Opioid consumption (in total morphine milligram equivalents (MME))
Secondary outcomes
Postpartum pain at 6 hours
Visual analog pain score with rest. Scale ranges from 0-10 with 0 indicating no pain and 10 indicating worst possible pain
Postpartum pain at 12 hours
Visual analog pain score with rest and movement. Scale ranges from 0-10 with 0 indicating no pain and 10 indicating worst possible pain
Postpartum pain at 24 hours
Visual analog pain score with rest and movement. Scale ranges from 0-10 with 0 indicating no pain and 10 indicating worst possible pain
Postpartum pain at 48 hours
Visual analog pain score with rest. Scale ranges from 0-10 with 0 indicating no pain and 10 indicating worst possible pain
Sponsors and contacts
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