Trial Outcomes & Findings for Opioid-free Analgesia for the Management of Acute Post-operative Pain Following Caesarean Section (NCT NCT04539249)
NCT ID: NCT04539249
Last Updated: 2023-07-20
Results Overview
Post-operative pain scores following caesarean section at 4 hours post-operative using the Numerical Rating Scale for pain. The Numerical Rating Scale for pain has a minimum score of 0, a maximum score of 10 and a range of 0-10, where higher scores mean a worse outcome (0= No pain at all, 5= Moderate pain and 10= Worst pain imaginable)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
324 participants
Primary outcome timeframe
4 hours post-operative
Results posted on
2023-07-20
Participant Flow
A total of 324 participants were enrolled and assessed for eligibility. A total of 224 of the enrolled participants were excluded from the study. Of the 224, one (1) declined to participate while the rest 223 did not meet the inclusion criteria.
Participant milestones
| Measure |
Magnesium Sulphate
Combination of intravenous magnesium sulphate, intravenous paracetamol and rectal diclofenac
Magnesium sulphate: 1g of paracetamol as an I.V infusion and 4g of magnesium sulphate as an I.V. bolus preoperatively. Continuous infusion of 1g/hr of magnesium sulphate intraoperatively and for the first 2 hours post-operatively. Further post-operatively, 100 mg of suppository diclofenac 12 hourly, intravenous paracetamol 1g 6 hourly, both over 24 hours.
N.B: Intramuscular pentazocine 30 mg (45 mg if patient is \> 70 kg) will be used as rescue analgesia as needed (that is, only on patients' request for further analgesia or following an assessment of moderate to severe pain despite the planned analgesic regimen) at least 4 hourly during the first 24 hours after caesarean section.
|
Pentazocine
Combination of intramuscular pentazocine, intravenous paracetamol and rectal diclofenac
Pentazocine: Post-operatively, suppository diclofenac 100mg 12 hourly, intramuscular pentazocine 30 mg (45 mg if patient is \> 70 kg) 6 hourly, intravenous paracetamol 1g 6 hourly, all for 24 hours.
N.B: Intramuscular pentazocine 30 mg (45 mg if patient is \> 70 kg) will be used as rescue analgesia as needed (that is, only on patients' request for further analgesia or following an assessment of moderate to severe pain despite the planned analgesic regimen) at least 4 hourly during the first 24 hours after caesarean section.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
Allocation
|
50
|
50
|
|
Overall Study
Intervention Per Protocol
|
49
|
50
|
|
Overall Study
Intervention NOT Per Protocol
|
1
|
0
|
|
Overall Study
Analyzed
|
50
|
50
|
|
Overall Study
Excluded From Analysis
|
0
|
0
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Opioid-free Analgesia for the Management of Acute Post-operative Pain Following Caesarean Section
Baseline characteristics by cohort
| Measure |
Magnesium Sulphate
n=50 Participants
Combination of intravenous magnesium sulphate, intravenous paracetamol and rectal diclofenac
Magnesium sulphate: 1g of paracetamol as an I.V infusion and 4g of magnesium sulphate as an I.V. bolus preoperatively. Continuous infusion of 1g/hr of magnesium sulphate intraoperatively and for the first 2 hours post-operatively. Further post-operatively, 100 mg of suppository diclofenac 12 hourly, intravenous paracetamol 1g 6 hourly, both over 24 hours.
N.B: Intramuscular pentazocine 30 mg (45 mg if patient is \> 70 kg) will be used as rescue analgesia as needed (that is, only on patients' request for further analgesia or following an assessment of moderate to severe pain despite the planned analgesic regimen) at least 4 hourly during the first 24 hours after caesarean section.
|
Pentazocine
n=50 Participants
Combination of intramuscular pentazocine, intravenous paracetamol and rectal diclofenac
Pentazocine: Post-operatively, suppository diclofenac 100mg 12 hourly, intramuscular pentazocine 30 mg (45 mg if patient is \> 70 kg) 6 hourly, intravenous paracetamol 1g 6 hourly, all for 24 hours.
N.B: Intramuscular pentazocine 30 mg (45 mg if patient is \> 70 kg) will be used as rescue analgesia as needed (that is, only on patients' request for further analgesia or following an assessment of moderate to severe pain despite the planned analgesic regimen) at least 4 hourly during the first 24 hours after caesarean section.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.7 years
STANDARD_DEVIATION 3.4 • n=5 Participants
|
30.8 years
STANDARD_DEVIATION 4.3 • n=7 Participants
|
31.3 years
STANDARD_DEVIATION 3.9 • n=5 Participants
|
|
Age, Customized
20-24
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Customized
25-29
|
12 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age, Customized
30-34
|
25 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Age, Customized
35-39
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Igbo
|
21 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ijaw
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Others
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
Nigeria
|
50 participants
n=5 Participants
|
50 participants
n=7 Participants
|
100 participants
n=5 Participants
|
|
Weight
|
84.5 Kilograms
STANDARD_DEVIATION 12.8 • n=5 Participants
|
77.9 Kilograms
STANDARD_DEVIATION 8.9 • n=7 Participants
|
81.2 Kilograms
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Parity
Nulliparous (Never carried a pregnancy up to 28 weeks gestation or beyond)
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Parity
Primiparous (Carried one (1) pregnancy up to 28 weeks and beyond, irrespective of outcome)
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Parity
Multiparous (Carried two (2) or more pregnancies up to 28 weeks and beyond, irrespective of outcome)
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 hours post-operativePost-operative pain scores following caesarean section at 4 hours post-operative using the Numerical Rating Scale for pain. The Numerical Rating Scale for pain has a minimum score of 0, a maximum score of 10 and a range of 0-10, where higher scores mean a worse outcome (0= No pain at all, 5= Moderate pain and 10= Worst pain imaginable)
Outcome measures
| Measure |
Magnesium Sulphate
n=50 Participants
Combination of intravenous magnesium sulphate, intravenous paracetamol and rectal diclofenac
Magnesium sulphate: 1g of paracetamol as an I.V infusion and 4g of magnesium sulphate as an I.V. bolus preoperatively. Continuous infusion of 1g/hr of magnesium sulphate intraoperatively and for the first 2 hours post-operatively. Further post-operatively, 100 mg of suppository diclofenac 12 hourly, intravenous paracetamol 1g 6 hourly, both over 24 hours.
N.B: Intramuscular pentazocine 30 mg (45 mg if patient is \> 70 kg) will be used as rescue analgesia as needed (that is, only on patients' request for further analgesia or following an assessment of moderate to severe pain despite the planned analgesic regimen) at least 4 hourly during the first 24 hours after caesarean section.
|
Pentazocine
n=50 Participants
Combination of intramuscular pentazocine, intravenous paracetamol and rectal diclofenac
Pentazocine: Post-operatively, suppository diclofenac 100mg 12 hourly, intramuscular pentazocine 30 mg (45 mg if patient is \> 70 kg) 6 hourly, intravenous paracetamol 1g 6 hourly, all for 24 hours.
N.B: Intramuscular pentazocine 30 mg (45 mg if patient is \> 70 kg) will be used as rescue analgesia as needed (that is, only on patients' request for further analgesia or following an assessment of moderate to severe pain despite the planned analgesic regimen) at least 4 hourly during the first 24 hours after caesarean section.
|
Pentazocine Only
Participants in the pentazocine arm of the study who received a combination of post-operative intramuscular pentazocine, intravenous paracetamol and rectal diclofenac
|
|---|---|---|---|
|
Post-operative Pain Scores Following Caesarean Section at 4 Hours Post-operative
|
2.98 score on a scale
Standard Deviation 1.18
|
3.16 score on a scale
Standard Deviation 1.45
|
—
|
PRIMARY outcome
Timeframe: 8 hours post-operativePost-operative pain scores following caesarean section at 8 hours post-operative using the Numerical Rating Scale for pain. The Numerical Rating Scale for pain has a minimum score of 0, a maximum score of 10 and a range of 0-10, where higher scores mean a worse outcome (0= No pain at all, 5= Moderate pain and 10= Worst pain imaginable)
Outcome measures
| Measure |
Magnesium Sulphate
n=50 Participants
Combination of intravenous magnesium sulphate, intravenous paracetamol and rectal diclofenac
Magnesium sulphate: 1g of paracetamol as an I.V infusion and 4g of magnesium sulphate as an I.V. bolus preoperatively. Continuous infusion of 1g/hr of magnesium sulphate intraoperatively and for the first 2 hours post-operatively. Further post-operatively, 100 mg of suppository diclofenac 12 hourly, intravenous paracetamol 1g 6 hourly, both over 24 hours.
N.B: Intramuscular pentazocine 30 mg (45 mg if patient is \> 70 kg) will be used as rescue analgesia as needed (that is, only on patients' request for further analgesia or following an assessment of moderate to severe pain despite the planned analgesic regimen) at least 4 hourly during the first 24 hours after caesarean section.
|
Pentazocine
n=50 Participants
Combination of intramuscular pentazocine, intravenous paracetamol and rectal diclofenac
Pentazocine: Post-operatively, suppository diclofenac 100mg 12 hourly, intramuscular pentazocine 30 mg (45 mg if patient is \> 70 kg) 6 hourly, intravenous paracetamol 1g 6 hourly, all for 24 hours.
N.B: Intramuscular pentazocine 30 mg (45 mg if patient is \> 70 kg) will be used as rescue analgesia as needed (that is, only on patients' request for further analgesia or following an assessment of moderate to severe pain despite the planned analgesic regimen) at least 4 hourly during the first 24 hours after caesarean section.
|
Pentazocine Only
Participants in the pentazocine arm of the study who received a combination of post-operative intramuscular pentazocine, intravenous paracetamol and rectal diclofenac
|
|---|---|---|---|
|
Post-operative Pain Scores Following Caesarean Section at 8 Hours Post-operative
|
2.58 score on a scale
Standard Deviation 1.81
|
2.68 score on a scale
Standard Deviation 1.63
|
—
|
PRIMARY outcome
Timeframe: 24 hours post-operativePost-operative pain scores following caesarean section at 24 hours post-operative using the Numerical Rating Scale for pain. The Numerical Rating Scale for pain has a minimum score of 0, a maximum score of 10 and a range of 0-10, where higher scores mean a worse outcome (0= No pain at all, 5= Moderate pain and 10= Worst pain imaginable)
Outcome measures
| Measure |
Magnesium Sulphate
n=50 Participants
Combination of intravenous magnesium sulphate, intravenous paracetamol and rectal diclofenac
Magnesium sulphate: 1g of paracetamol as an I.V infusion and 4g of magnesium sulphate as an I.V. bolus preoperatively. Continuous infusion of 1g/hr of magnesium sulphate intraoperatively and for the first 2 hours post-operatively. Further post-operatively, 100 mg of suppository diclofenac 12 hourly, intravenous paracetamol 1g 6 hourly, both over 24 hours.
N.B: Intramuscular pentazocine 30 mg (45 mg if patient is \> 70 kg) will be used as rescue analgesia as needed (that is, only on patients' request for further analgesia or following an assessment of moderate to severe pain despite the planned analgesic regimen) at least 4 hourly during the first 24 hours after caesarean section.
|
Pentazocine
n=50 Participants
Combination of intramuscular pentazocine, intravenous paracetamol and rectal diclofenac
Pentazocine: Post-operatively, suppository diclofenac 100mg 12 hourly, intramuscular pentazocine 30 mg (45 mg if patient is \> 70 kg) 6 hourly, intravenous paracetamol 1g 6 hourly, all for 24 hours.
N.B: Intramuscular pentazocine 30 mg (45 mg if patient is \> 70 kg) will be used as rescue analgesia as needed (that is, only on patients' request for further analgesia or following an assessment of moderate to severe pain despite the planned analgesic regimen) at least 4 hourly during the first 24 hours after caesarean section.
|
Pentazocine Only
Participants in the pentazocine arm of the study who received a combination of post-operative intramuscular pentazocine, intravenous paracetamol and rectal diclofenac
|
|---|---|---|---|
|
Post-operative Pain Scores Following Caesarean Section at 24 Hours Post-operative
|
2.06 score on a scale
Standard Deviation 1.42
|
2.37 score on a scale
Standard Deviation 1.54
|
—
|
PRIMARY outcome
Timeframe: 24 hours post-operativeWhether or not Pentazocine was used post-operatively
Outcome measures
| Measure |
Magnesium Sulphate
n=50 Participants
Combination of intravenous magnesium sulphate, intravenous paracetamol and rectal diclofenac
Magnesium sulphate: 1g of paracetamol as an I.V infusion and 4g of magnesium sulphate as an I.V. bolus preoperatively. Continuous infusion of 1g/hr of magnesium sulphate intraoperatively and for the first 2 hours post-operatively. Further post-operatively, 100 mg of suppository diclofenac 12 hourly, intravenous paracetamol 1g 6 hourly, both over 24 hours.
N.B: Intramuscular pentazocine 30 mg (45 mg if patient is \> 70 kg) will be used as rescue analgesia as needed (that is, only on patients' request for further analgesia or following an assessment of moderate to severe pain despite the planned analgesic regimen) at least 4 hourly during the first 24 hours after caesarean section.
|
Pentazocine
n=50 Participants
Combination of intramuscular pentazocine, intravenous paracetamol and rectal diclofenac
Pentazocine: Post-operatively, suppository diclofenac 100mg 12 hourly, intramuscular pentazocine 30 mg (45 mg if patient is \> 70 kg) 6 hourly, intravenous paracetamol 1g 6 hourly, all for 24 hours.
N.B: Intramuscular pentazocine 30 mg (45 mg if patient is \> 70 kg) will be used as rescue analgesia as needed (that is, only on patients' request for further analgesia or following an assessment of moderate to severe pain despite the planned analgesic regimen) at least 4 hourly during the first 24 hours after caesarean section.
|
Pentazocine Only
Participants in the pentazocine arm of the study who received a combination of post-operative intramuscular pentazocine, intravenous paracetamol and rectal diclofenac
|
|---|---|---|---|
|
Post-operative Pentazocine Use
Pentazocine used
|
46 Participants
|
50 Participants
|
—
|
|
Post-operative Pentazocine Use
Pentazocine NOT used
|
4 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: 24 hours post-operativeWhether or not pentazocine was used as rescue analgesia
Outcome measures
| Measure |
Magnesium Sulphate
n=50 Participants
Combination of intravenous magnesium sulphate, intravenous paracetamol and rectal diclofenac
Magnesium sulphate: 1g of paracetamol as an I.V infusion and 4g of magnesium sulphate as an I.V. bolus preoperatively. Continuous infusion of 1g/hr of magnesium sulphate intraoperatively and for the first 2 hours post-operatively. Further post-operatively, 100 mg of suppository diclofenac 12 hourly, intravenous paracetamol 1g 6 hourly, both over 24 hours.
N.B: Intramuscular pentazocine 30 mg (45 mg if patient is \> 70 kg) will be used as rescue analgesia as needed (that is, only on patients' request for further analgesia or following an assessment of moderate to severe pain despite the planned analgesic regimen) at least 4 hourly during the first 24 hours after caesarean section.
|
Pentazocine
n=50 Participants
Combination of intramuscular pentazocine, intravenous paracetamol and rectal diclofenac
Pentazocine: Post-operatively, suppository diclofenac 100mg 12 hourly, intramuscular pentazocine 30 mg (45 mg if patient is \> 70 kg) 6 hourly, intravenous paracetamol 1g 6 hourly, all for 24 hours.
N.B: Intramuscular pentazocine 30 mg (45 mg if patient is \> 70 kg) will be used as rescue analgesia as needed (that is, only on patients' request for further analgesia or following an assessment of moderate to severe pain despite the planned analgesic regimen) at least 4 hourly during the first 24 hours after caesarean section.
|
Pentazocine Only
Participants in the pentazocine arm of the study who received a combination of post-operative intramuscular pentazocine, intravenous paracetamol and rectal diclofenac
|
|---|---|---|---|
|
Pentazocine Use as Rescue Analgesia
Pentazocine used as rescue analgesia
|
46 Participants
|
0 Participants
|
—
|
|
Pentazocine Use as Rescue Analgesia
Pentazocine NOT used as rescue analgesia
|
4 Participants
|
50 Participants
|
—
|
PRIMARY outcome
Timeframe: 24 hours post-operativeFrequency of Pentazocine use per participant in each arm of the study and whether it was used as indicated in the protocol and/or for rescue analgesia
Outcome measures
| Measure |
Magnesium Sulphate
n=50 Participants
Combination of intravenous magnesium sulphate, intravenous paracetamol and rectal diclofenac
Magnesium sulphate: 1g of paracetamol as an I.V infusion and 4g of magnesium sulphate as an I.V. bolus preoperatively. Continuous infusion of 1g/hr of magnesium sulphate intraoperatively and for the first 2 hours post-operatively. Further post-operatively, 100 mg of suppository diclofenac 12 hourly, intravenous paracetamol 1g 6 hourly, both over 24 hours.
N.B: Intramuscular pentazocine 30 mg (45 mg if patient is \> 70 kg) will be used as rescue analgesia as needed (that is, only on patients' request for further analgesia or following an assessment of moderate to severe pain despite the planned analgesic regimen) at least 4 hourly during the first 24 hours after caesarean section.
|
Pentazocine
n=50 Participants
Combination of intramuscular pentazocine, intravenous paracetamol and rectal diclofenac
Pentazocine: Post-operatively, suppository diclofenac 100mg 12 hourly, intramuscular pentazocine 30 mg (45 mg if patient is \> 70 kg) 6 hourly, intravenous paracetamol 1g 6 hourly, all for 24 hours.
N.B: Intramuscular pentazocine 30 mg (45 mg if patient is \> 70 kg) will be used as rescue analgesia as needed (that is, only on patients' request for further analgesia or following an assessment of moderate to severe pain despite the planned analgesic regimen) at least 4 hourly during the first 24 hours after caesarean section.
|
Pentazocine Only
Participants in the pentazocine arm of the study who received a combination of post-operative intramuscular pentazocine, intravenous paracetamol and rectal diclofenac
|
|---|---|---|---|
|
Frequency and Nature of Pentazocine Use
Four times (as rescue analgesia)
|
0 Participants
|
0 Participants
|
—
|
|
Frequency and Nature of Pentazocine Use
Three times (as rescue analgesia)
|
0 Participants
|
0 Participants
|
—
|
|
Frequency and Nature of Pentazocine Use
Two times (as rescue analgesia)
|
11 Participants
|
0 Participants
|
—
|
|
Frequency and Nature of Pentazocine Use
Once (as rescue analgesia)
|
35 Participants
|
0 Participants
|
—
|
|
Frequency and Nature of Pentazocine Use
More than 4 times (per protocol + as rescue analgesia)
|
0 Participants
|
0 Participants
|
—
|
|
Frequency and Nature of Pentazocine Use
Four times (per protocol)
|
0 Participants
|
50 Participants
|
—
|
|
Frequency and Nature of Pentazocine Use
Not used at all
|
4 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: 24 hours post-operativeMean dose of Pentazocine used in each arm of the study
Outcome measures
| Measure |
Magnesium Sulphate
n=50 Participants
Combination of intravenous magnesium sulphate, intravenous paracetamol and rectal diclofenac
Magnesium sulphate: 1g of paracetamol as an I.V infusion and 4g of magnesium sulphate as an I.V. bolus preoperatively. Continuous infusion of 1g/hr of magnesium sulphate intraoperatively and for the first 2 hours post-operatively. Further post-operatively, 100 mg of suppository diclofenac 12 hourly, intravenous paracetamol 1g 6 hourly, both over 24 hours.
N.B: Intramuscular pentazocine 30 mg (45 mg if patient is \> 70 kg) will be used as rescue analgesia as needed (that is, only on patients' request for further analgesia or following an assessment of moderate to severe pain despite the planned analgesic regimen) at least 4 hourly during the first 24 hours after caesarean section.
|
Pentazocine
n=50 Participants
Combination of intramuscular pentazocine, intravenous paracetamol and rectal diclofenac
Pentazocine: Post-operatively, suppository diclofenac 100mg 12 hourly, intramuscular pentazocine 30 mg (45 mg if patient is \> 70 kg) 6 hourly, intravenous paracetamol 1g 6 hourly, all for 24 hours.
N.B: Intramuscular pentazocine 30 mg (45 mg if patient is \> 70 kg) will be used as rescue analgesia as needed (that is, only on patients' request for further analgesia or following an assessment of moderate to severe pain despite the planned analgesic regimen) at least 4 hourly during the first 24 hours after caesarean section.
|
Pentazocine Only
Participants in the pentazocine arm of the study who received a combination of post-operative intramuscular pentazocine, intravenous paracetamol and rectal diclofenac
|
|---|---|---|---|
|
Mean Dose of Pentazocine Used
|
52.83 Milligrams
Standard Deviation 21.85
|
164.40 Milligrams
Standard Deviation 28.59
|
—
|
SECONDARY outcome
Timeframe: Time of first administration of peri-operative analgesia to 2 hours postoperativePopulation: Number analyzed under severe (symptomatic) systolic hypotension (n=14; MgSo4 arm, n=5; Pentazocine arm ) and under severe (symptomatic) diastolic hypotension (n=24; MgSo4 arm, n=18; Pentazocine arm ) are subsets of the outcome measures systolic hypotension and diastolic hypotension with participant counts of (n=14; MgSo4 arm, n=5; Pentazocine arm ) and (n=24; MgSo4 arm, n=18; Pentazocine arm ) respectively
Number of participants with peri-operative adverse events including hypersensitivity reaction, respiratory depression, bradycardia, hypotension, nausea and vomiting, lightheadedness, presyncope, and any other adverse event recorded from the time of first administration of peri-operative analgesia to 2 hours postoperative
Outcome measures
| Measure |
Magnesium Sulphate
n=50 Participants
Combination of intravenous magnesium sulphate, intravenous paracetamol and rectal diclofenac
Magnesium sulphate: 1g of paracetamol as an I.V infusion and 4g of magnesium sulphate as an I.V. bolus preoperatively. Continuous infusion of 1g/hr of magnesium sulphate intraoperatively and for the first 2 hours post-operatively. Further post-operatively, 100 mg of suppository diclofenac 12 hourly, intravenous paracetamol 1g 6 hourly, both over 24 hours.
N.B: Intramuscular pentazocine 30 mg (45 mg if patient is \> 70 kg) will be used as rescue analgesia as needed (that is, only on patients' request for further analgesia or following an assessment of moderate to severe pain despite the planned analgesic regimen) at least 4 hourly during the first 24 hours after caesarean section.
|
Pentazocine
n=50 Participants
Combination of intramuscular pentazocine, intravenous paracetamol and rectal diclofenac
Pentazocine: Post-operatively, suppository diclofenac 100mg 12 hourly, intramuscular pentazocine 30 mg (45 mg if patient is \> 70 kg) 6 hourly, intravenous paracetamol 1g 6 hourly, all for 24 hours.
N.B: Intramuscular pentazocine 30 mg (45 mg if patient is \> 70 kg) will be used as rescue analgesia as needed (that is, only on patients' request for further analgesia or following an assessment of moderate to severe pain despite the planned analgesic regimen) at least 4 hourly during the first 24 hours after caesarean section.
|
Pentazocine Only
Participants in the pentazocine arm of the study who received a combination of post-operative intramuscular pentazocine, intravenous paracetamol and rectal diclofenac
|
|---|---|---|---|
|
Number of Participants With Peri-operative Adverse Events
Systolic hypotension · Present
|
14 Participants
|
5 Participants
|
—
|
|
Number of Participants With Peri-operative Adverse Events
Systolic hypotension · Absent
|
36 Participants
|
45 Participants
|
—
|
|
Number of Participants With Peri-operative Adverse Events
Severe (Symptomatic) diastolic hypotension · Present
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Peri-operative Adverse Events
Severe (Symptomatic) diastolic hypotension · Absent
|
23 Participants
|
18 Participants
|
—
|
|
Number of Participants With Peri-operative Adverse Events
Bradycardia · Present
|
0 Participants
|
2 Participants
|
—
|
|
Number of Participants With Peri-operative Adverse Events
Bradycardia · Absent
|
50 Participants
|
48 Participants
|
—
|
|
Number of Participants With Peri-operative Adverse Events
Severe (Symptomatic) systolic hypotension · Present
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Peri-operative Adverse Events
Severe (Symptomatic) systolic hypotension · Absent
|
13 Participants
|
5 Participants
|
—
|
|
Number of Participants With Peri-operative Adverse Events
Diastolic hypotension · Present
|
24 Participants
|
18 Participants
|
—
|
|
Number of Participants With Peri-operative Adverse Events
Diastolic hypotension · Absent
|
26 Participants
|
32 Participants
|
—
|
|
Number of Participants With Peri-operative Adverse Events
Vomiting · Present
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Peri-operative Adverse Events
Vomiting · Absent
|
49 Participants
|
50 Participants
|
—
|
|
Number of Participants With Peri-operative Adverse Events
Lightheadedness · Present
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Peri-operative Adverse Events
Lightheadedness · Absent
|
49 Participants
|
50 Participants
|
—
|
|
Number of Participants With Peri-operative Adverse Events
Presyncope · Present
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Peri-operative Adverse Events
Presyncope · Absent
|
49 Participants
|
50 Participants
|
—
|
SECONDARY outcome
Timeframe: First 24 hours post-operativeNumber of participants with post-operative adverse events including respiratory depression constipation, ileus, pruritus, urinary retention and any other adverse event recorded during the first 24 hours post-operative.
Outcome measures
| Measure |
Magnesium Sulphate
n=4 Participants
Combination of intravenous magnesium sulphate, intravenous paracetamol and rectal diclofenac
Magnesium sulphate: 1g of paracetamol as an I.V infusion and 4g of magnesium sulphate as an I.V. bolus preoperatively. Continuous infusion of 1g/hr of magnesium sulphate intraoperatively and for the first 2 hours post-operatively. Further post-operatively, 100 mg of suppository diclofenac 12 hourly, intravenous paracetamol 1g 6 hourly, both over 24 hours.
N.B: Intramuscular pentazocine 30 mg (45 mg if patient is \> 70 kg) will be used as rescue analgesia as needed (that is, only on patients' request for further analgesia or following an assessment of moderate to severe pain despite the planned analgesic regimen) at least 4 hourly during the first 24 hours after caesarean section.
|
Pentazocine
n=46 Participants
Combination of intramuscular pentazocine, intravenous paracetamol and rectal diclofenac
Pentazocine: Post-operatively, suppository diclofenac 100mg 12 hourly, intramuscular pentazocine 30 mg (45 mg if patient is \> 70 kg) 6 hourly, intravenous paracetamol 1g 6 hourly, all for 24 hours.
N.B: Intramuscular pentazocine 30 mg (45 mg if patient is \> 70 kg) will be used as rescue analgesia as needed (that is, only on patients' request for further analgesia or following an assessment of moderate to severe pain despite the planned analgesic regimen) at least 4 hourly during the first 24 hours after caesarean section.
|
Pentazocine Only
n=50 Participants
Participants in the pentazocine arm of the study who received a combination of post-operative intramuscular pentazocine, intravenous paracetamol and rectal diclofenac
|
|---|---|---|---|
|
Number of Participants With Post-operative Adverse Events
Absent
|
4 Participants
|
46 Participants
|
50 Participants
|
|
Number of Participants With Post-operative Adverse Events
Present
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At first and fifth minutes after birthApgar scores of the neonates delivered by the women who had caesarean section under the study, taken at first and fifth minutes after birth. Apgar score has a minimum score of 0, a maximum score of 10 and a range of 0-10, where higher scores mean a better outcome (0-3= low Apgar score, 4-6= moderately abnormal Apgar score and 7-10= reassuring Apgar score
Outcome measures
| Measure |
Magnesium Sulphate
n=50 Participants
Combination of intravenous magnesium sulphate, intravenous paracetamol and rectal diclofenac
Magnesium sulphate: 1g of paracetamol as an I.V infusion and 4g of magnesium sulphate as an I.V. bolus preoperatively. Continuous infusion of 1g/hr of magnesium sulphate intraoperatively and for the first 2 hours post-operatively. Further post-operatively, 100 mg of suppository diclofenac 12 hourly, intravenous paracetamol 1g 6 hourly, both over 24 hours.
N.B: Intramuscular pentazocine 30 mg (45 mg if patient is \> 70 kg) will be used as rescue analgesia as needed (that is, only on patients' request for further analgesia or following an assessment of moderate to severe pain despite the planned analgesic regimen) at least 4 hourly during the first 24 hours after caesarean section.
|
Pentazocine
n=50 Participants
Combination of intramuscular pentazocine, intravenous paracetamol and rectal diclofenac
Pentazocine: Post-operatively, suppository diclofenac 100mg 12 hourly, intramuscular pentazocine 30 mg (45 mg if patient is \> 70 kg) 6 hourly, intravenous paracetamol 1g 6 hourly, all for 24 hours.
N.B: Intramuscular pentazocine 30 mg (45 mg if patient is \> 70 kg) will be used as rescue analgesia as needed (that is, only on patients' request for further analgesia or following an assessment of moderate to severe pain despite the planned analgesic regimen) at least 4 hourly during the first 24 hours after caesarean section.
|
Pentazocine Only
Participants in the pentazocine arm of the study who received a combination of post-operative intramuscular pentazocine, intravenous paracetamol and rectal diclofenac
|
|---|---|---|---|
|
Apgar Scores of the Neonates
Apgar score at the 5th minute · Less than 4
|
0 Participants
|
1 Participants
|
—
|
|
Apgar Scores of the Neonates
Apgar score at the 1st minute · Less than 4
|
0 Participants
|
0 Participants
|
—
|
|
Apgar Scores of the Neonates
Apgar score at the 1st minute · 4-6
|
2 Participants
|
6 Participants
|
—
|
|
Apgar Scores of the Neonates
Apgar score at the 1st minute · 7-10
|
48 Participants
|
44 Participants
|
—
|
|
Apgar Scores of the Neonates
Apgar score at the 5th minute · 4-6
|
0 Participants
|
0 Participants
|
—
|
|
Apgar Scores of the Neonates
Apgar score at the 5th minute · 7-10
|
50 Participants
|
49 Participants
|
—
|
Adverse Events
Magnesium Sulphate Only
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Magnesium Sulphate and Pentazocine
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Pentazocine Only
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Magnesium Sulphate Only
n=4 participants at risk
.Participants in the magnesium sulphate arm of the study who received a combination of peri-operative intravenous magnesium sulphate, intravenous paracetamol, and post-operative rectal diclofenac, but DID NOT receive post-operative intramuscular pentazocine as rescue analgesia
|
Magnesium Sulphate and Pentazocine
n=46 participants at risk
Participants in the magnesium sulphate arm of the study who received a combination of peri-operative intravenous magnesium sulphate, intravenous paracetamol, and post-operative rectal diclofenac, and ALSO received post-operative intramuscular pentazocine as rescue analgesia
|
Pentazocine Only
n=50 participants at risk
Participants in the pentazocine arm of the study who received a combination of post-operative intramuscular pentazocine, intravenous paracetamol and rectal diclofenac
|
|---|---|---|---|
|
Cardiac disorders
Severe (symptomatic) hypotension
|
0.00%
0/4 • Pre-operative, intra-operative and first 24 hours post-operative
|
2.2%
1/46 • Number of events 1 • Pre-operative, intra-operative and first 24 hours post-operative
|
0.00%
0/50 • Pre-operative, intra-operative and first 24 hours post-operative
|
Other adverse events
| Measure |
Magnesium Sulphate Only
n=4 participants at risk
.Participants in the magnesium sulphate arm of the study who received a combination of peri-operative intravenous magnesium sulphate, intravenous paracetamol, and post-operative rectal diclofenac, but DID NOT receive post-operative intramuscular pentazocine as rescue analgesia
|
Magnesium Sulphate and Pentazocine
n=46 participants at risk
Participants in the magnesium sulphate arm of the study who received a combination of peri-operative intravenous magnesium sulphate, intravenous paracetamol, and post-operative rectal diclofenac, and ALSO received post-operative intramuscular pentazocine as rescue analgesia
|
Pentazocine Only
n=50 participants at risk
Participants in the pentazocine arm of the study who received a combination of post-operative intramuscular pentazocine, intravenous paracetamol and rectal diclofenac
|
|---|---|---|---|
|
Cardiac disorders
Mild (asymptomatic) systolic hypotension
|
0.00%
0/4 • Pre-operative, intra-operative and first 24 hours post-operative
|
0.00%
0/46 • Pre-operative, intra-operative and first 24 hours post-operative
|
10.0%
5/50 • Number of events 5 • Pre-operative, intra-operative and first 24 hours post-operative
|
|
Cardiac disorders
Mild (asymptomatic) diastolic hypotension
|
100.0%
4/4 • Number of events 4 • Pre-operative, intra-operative and first 24 hours post-operative
|
41.3%
19/46 • Number of events 19 • Pre-operative, intra-operative and first 24 hours post-operative
|
36.0%
18/50 • Number of events 18 • Pre-operative, intra-operative and first 24 hours post-operative
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/4 • Pre-operative, intra-operative and first 24 hours post-operative
|
0.00%
0/46 • Pre-operative, intra-operative and first 24 hours post-operative
|
4.0%
2/50 • Number of events 2 • Pre-operative, intra-operative and first 24 hours post-operative
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place