Trial Outcomes & Findings for Intravenous Paracetamol in Combination With Caudal Ropivacaine (NCT NCT03781505)
NCT ID: NCT03781505
Last Updated: 2024-08-16
Results Overview
The requirement of postoperative analgesia of the patient will be evaluated by using Children's Hospital of Eastern Ontario Pain Scale (CHEOPS). This scale has 5 domains. It includes crying, facial expression, verbal response, touching the wound and torso and leg movement. It is a behavioural scale and measures each domain on a numerical scale of 0 to 2. Minimum score is 0 while maximum score is 10. Aggregate score will be added. Score less than 4 will be consider adequate analgesia while score greater than 4 will be consider inadequate analgesia. CHEOPS Pain Score less than four in participants of C and P groups will be reported at different time points.
COMPLETED
PHASE4
64 participants
follow till 6 hours postoperatively
2024-08-16
Participant Flow
Excluded patients n = 5 Parenteral refusal 2, overweight 2, case cancellation 1
Participant milestones
| Measure |
Intravenous Paracetamol With Caudal Ropivacaine (Group P)
Patients in Group P received Caudal analgesia after the induction of anesthesia, whereas intravenous paracetamol was given approximately an hour before the end of surgery in a dose of 15mg.kg-1 over 15 to 20 minutes
|
Placebo (Group C)
Normal Saline (0.9%)
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
29
|
|
Overall Study
COMPLETED
|
30
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Intravenous Paracetamol With Caudal Ropivacaine
n=30 Participants
Paracetamol is widely accepted and most commonly used as an adjuvant for postoperative analgesia. It also improves the quality of recovery by attenuating the pain associated with the surgical position. Adverse effects associated with the paracetamol are rare \<1/10000, which includes malaise, increased level of hepatic transaminases and hypersensitivity reaction. It has been studied in combination with caudal analgesia with bupivacaine through the rectal route 7,8 with variable results.
Caudal anaesthesia is effective in alleviating pain below the umbilicus. Also if the caudal block is administered at the beginning of surgery, the effect will start wearing off 2 to 3 hours post surgery. Administration of paracetamol towards end of surgery may help with both these issues. In this study we aim to investigate the effect of adding intravenous paracetamol in combination with caudal analgesia with ropivacaine, hoping that it may improve quality of postoperative analgesia and recovery.
Paracetamol +caudal ropivacaine: Paracetamol + Ropivacaine
|
Placebo
n=29 Participants
Intravenous Normal Saline with Caudal Ropivacaine
Placebo: Caudal ropivacaine
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
5.00 years
n=30 Participants
|
4.10 years
n=29 Participants
|
4.60 years
n=59 Participants
|
|
Sex/Gender, Customized
Male
|
30 Participants
n=30 Participants
|
29 Participants
n=29 Participants
|
59 Participants
n=59 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
BMI
|
14.1 kg/m^2
n=30 Participants
|
14.8 kg/m^2
n=29 Participants
|
14.7 kg/m^2
n=59 Participants
|
|
Heart rate
|
104 beats per minute
STANDARD_DEVIATION 13.3 • n=30 Participants
|
103 beats per minute
STANDARD_DEVIATION 16.1 • n=29 Participants
|
103 beats per minute
STANDARD_DEVIATION 14.6 • n=59 Participants
|
|
Surgical Time
|
65.0 Minutes
n=30 Participants
|
65.0 Minutes
n=29 Participants
|
65.0 Minutes
n=59 Participants
|
|
Anaesthesia Time
|
109 Minutes
n=30 Participants
|
120 Minutes
n=29 Participants
|
111 Minutes
n=59 Participants
|
|
Blood Pressure (systolic)
|
99.0 mmHg
n=30 Participants
|
92.0 mmHg
n=29 Participants
|
95.0 mmHg
n=59 Participants
|
|
Blood Pressure (diastolic)
|
60.0 mmHg
n=30 Participants
|
51.0 mmHg
n=29 Participants
|
53.0 mmHg
n=59 Participants
|
PRIMARY outcome
Timeframe: follow till 6 hours postoperativelyThe requirement of postoperative analgesia of the patient will be evaluated by using Children's Hospital of Eastern Ontario Pain Scale (CHEOPS). This scale has 5 domains. It includes crying, facial expression, verbal response, touching the wound and torso and leg movement. It is a behavioural scale and measures each domain on a numerical scale of 0 to 2. Minimum score is 0 while maximum score is 10. Aggregate score will be added. Score less than 4 will be consider adequate analgesia while score greater than 4 will be consider inadequate analgesia. CHEOPS Pain Score less than four in participants of C and P groups will be reported at different time points.
Outcome measures
| Measure |
Intravenous Paracetamol With Caudal Ropivacaine (Group P)
n=30 Participants
Patients in Group P received Caudal analgesia after the induction of anesthesia, whereas intravenous paracetamol was given approximately an hour before the end of surgery in a dose of 15mg.kg-1 over 15 to 20 minutes
|
Placebo (Group C)
n=29 Participants
Normal Saline (0.9%)
|
|---|---|---|
|
Postoperative Analgesia Requirement
15 minutes
|
23 Participants
|
25 Participants
|
|
Postoperative Analgesia Requirement
30 minutes
|
24 Participants
|
21 Participants
|
|
Postoperative Analgesia Requirement
1 hour
|
26 Participants
|
25 Participants
|
|
Postoperative Analgesia Requirement
2 hour
|
30 Participants
|
28 Participants
|
|
Postoperative Analgesia Requirement
4 hour
|
29 Participants
|
29 Participants
|
|
Postoperative Analgesia Requirement
6 hour
|
29 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: follow till 4 hours postoperativelySedation will be assessed by using Pasero Opioid-Induced Sedation Scale (POSS). This scale measures sedation on numerical score of 0 to 4. Minimum score is 0 while maximum score is 4. It comprises of; 0: awake; 1: mild sedation; 2: sleeping, but able to wake; 3: Frequently drowsy, arousable, drifts off to sleep during conversation, unable to wake and 4: Somnolent, minimal or no response to verbal or physical stimulation. A POSS score of 0, 1, or 2 indicates an acceptable level of sedation, whereas a score of 3 or 4 indicates over-sedation and the need for a reversal agent. This score is just a numerical number with no other value attached to it.
Outcome measures
| Measure |
Intravenous Paracetamol With Caudal Ropivacaine (Group P)
n=30 Participants
Patients in Group P received Caudal analgesia after the induction of anesthesia, whereas intravenous paracetamol was given approximately an hour before the end of surgery in a dose of 15mg.kg-1 over 15 to 20 minutes
|
Placebo (Group C)
n=29 Participants
Normal Saline (0.9%)
|
|---|---|---|
|
Sedation
Baseline (0-2)
|
23 Participants
|
23 Participants
|
|
Sedation
Baseline (3-4)
|
7 Participants
|
6 Participants
|
|
Sedation
30 min (0-2)
|
26 Participants
|
25 Participants
|
|
Sedation
30 min (3-4)
|
4 Participants
|
4 Participants
|
|
Sedation
1 hr (0-2)
|
30 Participants
|
29 Participants
|
|
Sedation
1 hr (3-4)
|
0 Participants
|
0 Participants
|
|
Sedation
2 hr (0-2)
|
30 Participants
|
29 Participants
|
|
Sedation
2 hr (3-4)
|
0 Participants
|
0 Participants
|
|
Sedation
4 hr (0-2)
|
30 Participants
|
29 Participants
|
|
Sedation
4 hr 3-4
|
0 Participants
|
0 Participants
|
Adverse Events
Intravenous Paracetamol With Caudal Ropivacaine (Group P)
Placebo (Group C)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place