drugset / Trial / NCT02440399
To Compare the Efficacy and Patients' Satisfaction for the Treatment of Post Cesarean Pain of Two Protocols: Oral Medications in Fixed Time Interval Administration Versus Spinal Morphine
RandomizedParallel-groupOpen-labelTreatment
Summary
Cesarean deliveries are prevalent. Unlike other operations, quick recovery is required for the mother to nurture the newborn child and establishing an appropriate mother-child bonding.
Timeline
- Start
- 2015-07
- Primary completion
- 2017-05
- Completion
- 2017-05
Outcome
Missed primary endpoint
paper The oral analgesia group compared to the spinal-morphine group had similar mean pain intensity (AUC (120 ± 35 versus 121 ± 31, respectively; p = 0.8) PMID 34463805 ↗
paper but more events of moderate-to-severe breakthrough pain (4.8 ± 2 versus 3.8 ± 1.7, respectively; p = 0.0002). PMID 34463805 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acetaminophen | Small molecule | 650 mg | Oral |
| Subject | Diclofenac | Other / unclassified | 100 mg | Oral |
| Subject | Morphine | Other / unclassified | 150 ug | Intrathecal |
| Subject | Tramadol | Other / unclassified | 75 mg | Intravenous |
| Background | Oxycodone | Other / unclassified | 5 mg | Oral |
Indications
No indication recorded.