Phase 4
N=59
Intravenous Paracetamol in Combination With Caudal Ropivacaine
Postoperative Analgesia
Bottom Line
View on ClinicalTrials.gov: NCT03781505 ↗Enrolled (actual)
59
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Postoperative Analgesia Requirement — 23; 25; 24; 21 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Paracetamol +caudal ropivacaine (Drug); Placebo (Drug)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- Aga Khan University
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative Analgesia Requirement |
23; 25; 24; 21; 26; 25 | — |
| SECONDARY Sedation |
23; 23; 7; 6; 26; 25 | — |
Summary
To investigate whether the addition of intravenous paracetamol with caudal ropivacaine leads to better quality of postoperative recovery in patients undergoing hypospadius repair than caudal ropivacaine alone. The quality of recovery will be judged by postoperative analgesia requirement and lesser agitation in the postoperative period.
Eligibility Criteria
Inclusion Criteria
- Age 3-10 years
- ASA (American Society of Anesthesiologists) I and II
- Undergoing hypospadias repair surgery
Exclusion Criteria
- Coagulopathy
- Aspirin or any other analgesic ingestion in the preceding week
- Preexisting neurological or spinal disease
- Hepatic, renal disease and malnutrition
- Severe hypovolemia
- Uncontrolled convulsions
- Refusal of the parents
- Local Skin infection at the puncture site
- Allergy to local anesthetics
- Patient previously involved in other studies
Data sourced from ClinicalTrials.gov (NCT03781505). 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.