Acute Post-operative Pain Following Caesarean Section
Conditions
Brief summary
Background: Multimodal analgesia; a combination of opioid and non-opioid analgesics, for management of acute post-operative pain significantly reduces the incidence of adverse effects associated with liberal post-operative opioid use including sedation, respiratory depression, constipation, ileus, urinary retention, delayed recovery, addiction etc. However, opioid addiction remains a worsening public health problem and have followed administration of opioid analgesics for post-operative pain and subsequent chronic use in many addicts; especially the opioid naive. Caesarean section is a commonly performed surgery and is a common source of first exposure to opioids in women. Trend in post-operative analgesia is moving towards opioid-free (multimodal) analgesia; a combination of non-opioid and adjuvant analgesics. Magnesium sulphate is an adjuvant analgesic. When administered peri-operatively, it has been reported to prolong the duration of spinal anaesthesia, decrease post-operative pain and opioid use without adverse effect. Aim: To determine the effectiveness and safety of a combination of peri-operative intravenous magnesium sulphate, intravenous paracetamol, and post-operative rectal diclofenac as opioid-free, multimodal analgesia for management of acute post-operative pain after a caesarean section. Null Hypothesis: Combination of intravenous magnesium sulphate, intravenous paracetamol, and rectal diclofenac as analgesia regimen for acute post-operative pain after a caesarean section is not as effective and safe as a routine opioid-based multimodal analgesia regimen used in the study setting. Alternate Hypothesis: Combination of intravenous magnesium sulphate, intravenous paracetamol, and rectal diclofenac as analgesia regimen for acute post-operative pain after a caesarean section is as effective and safe as a routine opioid-based multimodal analgesia regimen used in the study setting. Materials and Methods: A randomized clinical trial, comparing a combination of peri-operative intravenous magnesium sulphate, intravenous paracetamol, and post-operative rectal diclofenac with an opioid-based multimodal regimen as control. Eligible patients will be consecutively selected from among women booked for caesarean section at the Federal Medical Centre, Yenagoa. Control group will receive a combination of post-operative intramuscular pentazocine, intravenous paracetamol and rectal diclofenac. Pain intensity will be determined in both groups and compared. Need for rescue opioid analgesic will be determined in both groups and compared. Incidence of any adverse event in both groups will be determined.
Interventions
DRUGMagnesium 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.
DRUGPentazocine
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.
Sponsors
Olakunle Ifeoluwa Makinde
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Pregnant women booked for elective, scheduled and urgent caesarean section at the Federal Medical Centre, Yenagoa, Bayelsa State during the study period, * Pregnant women who give consent to participate in the study.
Exclusion criteria
* Pregnant women with active peptic ulcer disease, active liver disease, hepatic failure, and renal failure, * Pregnant women with previous history of ischaemic heart disease/myocardial infarction, heart failure, venous thrombosis and stroke, * Hypersensitivity to pentazocine, paracetamol, diclofenac or magnesium sulphate, * Pregnant women with history of non-medical use (abuse) of opioids, * Pregnant women on magnesium sulphate or have a clinical indication to receive magnesium sulphate, * Pregnant women booked for emergency caesarean section (because the urgency may not allow time for adequate patient counseling before recruitment) * Pregnant women booked for caesarean section under general anaesthesia or epidural anaesthesia, * Pregnant women who can neither communicate in english nor colloquial english.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Dose of Pentazocine Used | 24 hours post-operative | Mean dose of Pentazocine used in each arm of the study |
| Post-operative Pentazocine Use | 24 hours post-operative | Whether or not Pentazocine was used post-operatively |
| Pentazocine Use as Rescue Analgesia | 24 hours post-operative | Whether or not pentazocine was used as rescue analgesia |
| Frequency and Nature of Pentazocine Use | 24 hours post-operative | Frequency 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 |
| Post-operative Pain Scores Following Caesarean Section at 4 Hours Post-operative | 4 hours post-operative | 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) |
| Post-operative Pain Scores Following Caesarean Section at 8 Hours Post-operative | 8 hours post-operative | Post-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) |
| Post-operative Pain Scores Following Caesarean Section at 24 Hours Post-operative | 24 hours post-operative | Post-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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Post-operative Adverse Events | First 24 hours post-operative | Number 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. |
| Apgar Scores of the Neonates | At first and fifth minutes after birth | Apgar 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 |
| Number of Participants With Peri-operative Adverse Events | Time of first administration of peri-operative analgesia to 2 hours postoperative | 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 |
Countries
Nigeria
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 50 |
| 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. | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Magnesium Sulphate | Pentazocine | Total |
|---|---|---|---|
| Age, Continuous | 31.7 years STANDARD_DEVIATION 3.4 | 30.8 years STANDARD_DEVIATION 4.3 | 31.3 years STANDARD_DEVIATION 3.9 |
| Age, Customized 20-24 | 0 Participants | 1 Participants | 1 Participants |
| Age, Customized 25-29 | 12 Participants | 19 Participants | 31 Participants |
| Age, Customized 30-34 | 25 Participants | 16 Participants | 41 Participants |
| Age, Customized 35-39 | 13 Participants | 14 Participants | 27 Participants |
| Parity Multiparous (Carried two (2) or more pregnancies up to 28 weeks and beyond, irrespective of outcome) | 33 Participants | 33 Participants | 66 Participants |
| Parity Nulliparous (Never carried a pregnancy up to 28 weeks gestation or beyond) | 6 Participants | 11 Participants | 17 Participants |
| Parity Primiparous (Carried one (1) pregnancy up to 28 weeks and beyond, irrespective of outcome) | 11 Participants | 6 Participants | 17 Participants |
| Race/Ethnicity, Customized Igbo | 21 Participants | 18 Participants | 39 Participants |
| Race/Ethnicity, Customized Ijaw | 23 Participants | 20 Participants | 43 Participants |
| Race/Ethnicity, Customized Others | 6 Participants | 12 Participants | 18 Participants |
| Region of Enrollment Nigeria | 50 participants | 50 participants | 100 participants |
| Sex: Female, Male Female | 50 Participants | 50 Participants | 100 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Weight | 84.5 Kilograms STANDARD_DEVIATION 12.8 | 77.9 Kilograms STANDARD_DEVIATION 8.9 | 81.2 Kilograms STANDARD_DEVIATION 11.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 46 | 0 / 50 |
| other Total, other adverse events | 4 / 4 | 19 / 46 | 20 / 50 |
| serious Total, serious adverse events | 0 / 4 | 1 / 46 | 0 / 50 |
Outcome results
Primary
Frequency and Nature of Pentazocine Use
Frequency 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
Time frame: 24 hours post-operative
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Magnesium Sulphate | Frequency and Nature of Pentazocine Use | Four times (as rescue analgesia) | 0 Participants |
| Magnesium Sulphate | Frequency and Nature of Pentazocine Use | Two times (as rescue analgesia) | 11 Participants |
| Magnesium Sulphate | Frequency and Nature of Pentazocine Use | Four times (per protocol) | 0 Participants |
| Magnesium Sulphate | Frequency and Nature of Pentazocine Use | Once (as rescue analgesia) | 35 Participants |
| Magnesium Sulphate | Frequency and Nature of Pentazocine Use | Three times (as rescue analgesia) | 0 Participants |
| Magnesium Sulphate | Frequency and Nature of Pentazocine Use | Not used at all | 4 Participants |
| Magnesium Sulphate | Frequency and Nature of Pentazocine Use | More than 4 times (per protocol + as rescue analgesia) | 0 Participants |
| Pentazocine | Frequency and Nature of Pentazocine Use | Not used at all | 0 Participants |
| Pentazocine | Frequency and Nature of Pentazocine Use | More than 4 times (per protocol + as rescue analgesia) | 0 Participants |
| Pentazocine | Frequency and Nature of Pentazocine Use | Four times (per protocol) | 50 Participants |
| Pentazocine | Frequency and Nature of Pentazocine Use | Four times (as rescue analgesia) | 0 Participants |
| Pentazocine | Frequency and Nature of Pentazocine Use | Three times (as rescue analgesia) | 0 Participants |
| Pentazocine | Frequency and Nature of Pentazocine Use | Two times (as rescue analgesia) | 0 Participants |
| Pentazocine | Frequency and Nature of Pentazocine Use | Once (as rescue analgesia) | 0 Participants |
Primary
Mean Dose of Pentazocine Used
Mean dose of Pentazocine used in each arm of the study
Time frame: 24 hours post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Magnesium Sulphate | Mean Dose of Pentazocine Used | 52.83 Milligrams | Standard Deviation 21.85 |
| Pentazocine | Mean Dose of Pentazocine Used | 164.40 Milligrams | Standard Deviation 28.59 |
Primary
Pentazocine Use as Rescue Analgesia
Whether or not pentazocine was used as rescue analgesia
Time frame: 24 hours post-operative
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Magnesium Sulphate | Pentazocine Use as Rescue Analgesia | Pentazocine NOT used as rescue analgesia | 4 Participants |
| Magnesium Sulphate | Pentazocine Use as Rescue Analgesia | Pentazocine used as rescue analgesia | 46 Participants |
| Pentazocine | Pentazocine Use as Rescue Analgesia | Pentazocine used as rescue analgesia | 0 Participants |
| Pentazocine | Pentazocine Use as Rescue Analgesia | Pentazocine NOT used as rescue analgesia | 50 Participants |
Primary
Post-operative Pain Scores Following Caesarean Section at 24 Hours Post-operative
Post-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)
Time frame: 24 hours post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Magnesium Sulphate | Post-operative Pain Scores Following Caesarean Section at 24 Hours Post-operative | 2.06 score on a scale | Standard Deviation 1.42 |
| Pentazocine | Post-operative Pain Scores Following Caesarean Section at 24 Hours Post-operative | 2.37 score on a scale | Standard Deviation 1.54 |
Primary
Post-operative Pain Scores Following Caesarean Section at 4 Hours Post-operative
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)
Time frame: 4 hours post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Magnesium Sulphate | Post-operative Pain Scores Following Caesarean Section at 4 Hours Post-operative | 2.98 score on a scale | Standard Deviation 1.18 |
| Pentazocine | Post-operative Pain Scores Following Caesarean Section at 4 Hours Post-operative | 3.16 score on a scale | Standard Deviation 1.45 |
Primary
Post-operative Pain Scores Following Caesarean Section at 8 Hours Post-operative
Post-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)
Time frame: 8 hours post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Magnesium Sulphate | Post-operative Pain Scores Following Caesarean Section at 8 Hours Post-operative | 2.58 score on a scale | Standard Deviation 1.81 |
| Pentazocine | Post-operative Pain Scores Following Caesarean Section at 8 Hours Post-operative | 2.68 score on a scale | Standard Deviation 1.63 |
Primary
Post-operative Pentazocine Use
Whether or not Pentazocine was used post-operatively
Time frame: 24 hours post-operative
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Magnesium Sulphate | Post-operative Pentazocine Use | Pentazocine used | 46 Participants |
| Magnesium Sulphate | Post-operative Pentazocine Use | Pentazocine NOT used | 4 Participants |
| Pentazocine | Post-operative Pentazocine Use | Pentazocine used | 50 Participants |
| Pentazocine | Post-operative Pentazocine Use | Pentazocine NOT used | 0 Participants |
Secondary
Apgar Scores of the Neonates
Apgar 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
Time frame: At first and fifth minutes after birth
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Magnesium Sulphate | Apgar Scores of the Neonates | Apgar score at the 1st minute | Less than 4 | 0 Participants |
| Magnesium Sulphate | Apgar Scores of the Neonates | Apgar score at the 1st minute | 4-6 | 2 Participants |
| Magnesium Sulphate | Apgar Scores of the Neonates | Apgar score at the 1st minute | 7-10 | 48 Participants |
| Magnesium Sulphate | Apgar Scores of the Neonates | Apgar score at the 5th minute | Less than 4 | 0 Participants |
| Magnesium Sulphate | Apgar Scores of the Neonates | Apgar score at the 5th minute | 4-6 | 0 Participants |
| Magnesium Sulphate | Apgar Scores of the Neonates | Apgar score at the 5th minute | 7-10 | 50 Participants |
| Pentazocine | Apgar Scores of the Neonates | Apgar score at the 5th minute | 4-6 | 0 Participants |
| Pentazocine | Apgar Scores of the Neonates | Apgar score at the 1st minute | Less than 4 | 0 Participants |
| Pentazocine | Apgar Scores of the Neonates | Apgar score at the 5th minute | Less than 4 | 1 Participants |
| Pentazocine | Apgar Scores of the Neonates | Apgar score at the 1st minute | 4-6 | 6 Participants |
| Pentazocine | Apgar Scores of the Neonates | Apgar score at the 5th minute | 7-10 | 49 Participants |
| Pentazocine | Apgar Scores of the Neonates | Apgar score at the 1st minute | 7-10 | 44 Participants |
Secondary
Number of Participants With Peri-operative Adverse Events
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
Time frame: Time of first administration of peri-operative analgesia to 2 hours postoperative
Population: 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
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Magnesium Sulphate | Number of Participants With Peri-operative Adverse Events | Bradycardia | Present | 0 Participants |
| Magnesium Sulphate | Number of Participants With Peri-operative Adverse Events | Bradycardia | Absent | 50 Participants |
| Magnesium Sulphate | Number of Participants With Peri-operative Adverse Events | Systolic hypotension | Present | 14 Participants |
| Magnesium Sulphate | Number of Participants With Peri-operative Adverse Events | Systolic hypotension | Absent | 36 Participants |
| Magnesium Sulphate | Number of Participants With Peri-operative Adverse Events | Severe (Symptomatic) systolic hypotension | Present | 1 Participants |
| Magnesium Sulphate | Number of Participants With Peri-operative Adverse Events | Severe (Symptomatic) systolic hypotension | Absent | 13 Participants |
| Magnesium Sulphate | Number of Participants With Peri-operative Adverse Events | Diastolic hypotension | Present | 24 Participants |
| Magnesium Sulphate | Number of Participants With Peri-operative Adverse Events | Diastolic hypotension | Absent | 26 Participants |
| Magnesium Sulphate | Number of Participants With Peri-operative Adverse Events | Severe (Symptomatic) diastolic hypotension | Present | 1 Participants |
| Magnesium Sulphate | Number of Participants With Peri-operative Adverse Events | Severe (Symptomatic) diastolic hypotension | Absent | 23 Participants |
| Magnesium Sulphate | Number of Participants With Peri-operative Adverse Events | Vomiting | Present | 1 Participants |
| Magnesium Sulphate | Number of Participants With Peri-operative Adverse Events | Vomiting | Absent | 49 Participants |
| Magnesium Sulphate | Number of Participants With Peri-operative Adverse Events | Lightheadedness | Present | 1 Participants |
| Magnesium Sulphate | Number of Participants With Peri-operative Adverse Events | Lightheadedness | Absent | 49 Participants |
| Magnesium Sulphate | Number of Participants With Peri-operative Adverse Events | Presyncope | Present | 1 Participants |
| Magnesium Sulphate | Number of Participants With Peri-operative Adverse Events | Presyncope | Absent | 49 Participants |
| Pentazocine | Number of Participants With Peri-operative Adverse Events | Presyncope | Absent | 50 Participants |
| Pentazocine | Number of Participants With Peri-operative Adverse Events | Bradycardia | Present | 2 Participants |
| Pentazocine | Number of Participants With Peri-operative Adverse Events | Severe (Symptomatic) diastolic hypotension | Present | 0 Participants |
| Pentazocine | Number of Participants With Peri-operative Adverse Events | Bradycardia | Absent | 48 Participants |
| Pentazocine | Number of Participants With Peri-operative Adverse Events | Lightheadedness | Present | 0 Participants |
| Pentazocine | Number of Participants With Peri-operative Adverse Events | Systolic hypotension | Present | 5 Participants |
| Pentazocine | Number of Participants With Peri-operative Adverse Events | Severe (Symptomatic) diastolic hypotension | Absent | 18 Participants |
| Pentazocine | Number of Participants With Peri-operative Adverse Events | Systolic hypotension | Absent | 45 Participants |
| Pentazocine | Number of Participants With Peri-operative Adverse Events | Presyncope | Present | 0 Participants |
| Pentazocine | Number of Participants With Peri-operative Adverse Events | Severe (Symptomatic) systolic hypotension | Present | 0 Participants |
| Pentazocine | Number of Participants With Peri-operative Adverse Events | Vomiting | Present | 0 Participants |
| Pentazocine | Number of Participants With Peri-operative Adverse Events | Severe (Symptomatic) systolic hypotension | Absent | 5 Participants |
| Pentazocine | Number of Participants With Peri-operative Adverse Events | Lightheadedness | Absent | 50 Participants |
| Pentazocine | Number of Participants With Peri-operative Adverse Events | Diastolic hypotension | Present | 18 Participants |
| Pentazocine | Number of Participants With Peri-operative Adverse Events | Vomiting | Absent | 50 Participants |
| Pentazocine | Number of Participants With Peri-operative Adverse Events | Diastolic hypotension | Absent | 32 Participants |
Secondary
Number of Participants With Post-operative Adverse Events
Number 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.
Time frame: First 24 hours post-operative
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Magnesium Sulphate | Number of Participants With Post-operative Adverse Events | Present | 0 Participants |
| Magnesium Sulphate | Number of Participants With Post-operative Adverse Events | Absent | 4 Participants |
| Pentazocine | Number of Participants With Post-operative Adverse Events | Present | 0 Participants |
| Pentazocine | Number of Participants With Post-operative Adverse Events | Absent | 46 Participants |
| Pentazocine Only | Number of Participants With Post-operative Adverse Events | Present | 0 Participants |
| Pentazocine Only | Number of Participants With Post-operative Adverse Events | Absent | 50 Participants |