Phase 4
Completed N=70
Prospective Effect of Intravenous Ketorolac on Opioid Use, EBL and Complications Following Cesarean Delivery
Analgesia, Obstetrical · postpartum hemorrhage · Opioid Use Disorder · Nonsteroidals (NSAIDs)Toxicity
Source: ClinicalTrials.gov NCT02509312 ↗
Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcomePrimary: Estimated Blood Loss (EBL) — 900; 800 ml — p=0.34
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
In this randomized, double-blind control trial to evaluate the effect of ketorolac given at the time of cord clamp has on estimated blood loss and postcesarean pain control. Patients will be randomized to either placebo or ketorolac prior to surgery. Those randomized to ketorolac will receive ketorolac at cord clamp and three additional doses every 6 hours (total 4 doses/24 hours). Those in the placebo group will receive normal saline during those time periods. Our primary outcome is to assess whether intra-operative ketorolac increases the estimated blood loss during Cesarean delivery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Estimated Blood Loss (EBL) |
900; 800 | 0.34 |
| SECONDARY Post-Partum Hemorrhage |
7; 4 | .257 |
| SECONDARY Corrected Change in Hct on POD1. |
-5.1; -3.5 | 0.085 |
| SECONDARY Uterotonic Doses |
0; 0 | 0.164 |
| SECONDARY Units of Packed Reb Blood Cell Transfused |
0; 0 | 1.000 |
| SECONDARY Hydromorphone Use |
17; 10; 11; 20 | 0.0367 sig |
| SECONDARY Total Hydromorphone Dose |
0; 0.2 | 0.0231 sig |
| SECONDARY Anti-emetic Doses |
0; 0 | 0.467 |
| SECONDARY Pruritus Doses |
0; 0 | 0.273 |
| SECONDARY Percentile Change in Systolic Blood Pressure at 6,12, and 24 Hours |
-2.0; -0.6; -9.10; -2.85; -5.9; -3.5 | 0.0162 sig |
| SECONDARY Percentile Change in Diastolic Blood Pressure (DBP) at 6,12, and 24 Hours |
12.30; 7.6; 8.8; 8.8; 12.0; 11.1 | — |
| SECONDARY Change in Pain Score Post-Cesarean Delivery |
0; 0; 0; 0; 0; 0 | 0.048 sig |
Eligibility Criteria
Inclusion Criteria
- Patients undergoing a scheduled or non-scheduled, non-urgent primary or repeat Cesarean delivery between 37-42 weeks gestational age,
- Viable singleton intra-uterine pregnancy,
- Patients undergoing a scheduled or unscheduled, non-emergent/non-urgent Cesarean delivery for placenta previa or vasa previa,
- Neuraxial anesthesia with combined spinal-epidural placed for surgery,
- Patients must be 18 years or older as well as willing and able to provide informed consent.
Exclusion Criteria
- Patients unable or unwilling to provide informed consent,
- Urgent or emergent Cesarean delivery
- Multiple fetal gestations (>1 intrauterine pregnancy),
- Cesarean delivery for bleeding such as placental abruption or actively bleeding placenta previa or vasa previa,
- Contraindication to NSAID use eg: allergy, chronic renal disease,
- Patients with acute or chronic platelet dysfunction (e.g.: idiopathic thrombocytopenic purpura, HELLP syndrome),
- Platelets 1000 ml prior to cord clamp
Data sourced from ClinicalTrials.gov (NCT02509312). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.