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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnesium sulphate | Experimental | Combination of intravenous magnesium sulphate, intravenous paracetamol and rectal diclofenac |
|
| Pentazocine | Active Comparator | Combination of intramuscular pentazocine, intravenous paracetamol and rectal diclofenac |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium sulphate | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 4 hours post-operative |
| 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) | 8 hours post-operative |
| 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) | 24 hours post-operative |
| Post-operative Pentazocine Use | Whether or not Pentazocine was used post-operatively | 24 hours post-operative |
| Pentazocine Use as Rescue Analgesia | Whether or not pentazocine was used as rescue analgesia | 24 hours post-operative |
| Frequency and Nature of Pentazocine Use |
| Measure | Description | Time Frame |
|---|---|---|
| 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 of first administration of peri-operative analgesia to 2 hours postoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olakunle I Makinde, MBChB, MWACS | Federal Medical Centre, Yenagoa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal Medical Centre, Yenagoa | Yenagoa | Bayelsa State | 560231 | Nigeria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24872720 | Background | Vadivelu N, Mitra S, Schermer E, Kodumudi V, Kaye AD, Urman RD. Preventive analgesia for postoperative pain control: a broader concept. Local Reg Anesth. 2014 May 29;7:17-22. doi: 10.2147/LRA.S62160. eCollection 2014. | |
| Background | Kim M. An opioid success story: efforts to minimize painkillers after surgery appear to be working. Johannesburg, South Africa: The Conversation Africa, Inc.; 2019. | ||
| Background | Johnson SR. Hospitals look to cut opioids from surgery and beyond. Detroit, Michigan: Crain communications, Inc.; 2019. | ||
| 31816306 |
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All Individual Participant Data that underlie results in a publication
Starting 3 months after publication
Open access
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Mean | Standard Deviation | score on a scale | 4 hours post-operative |
|
Pre-operative, intra-operative and first 24 hours post-operative
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Magnesium Sulphate Only | .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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe (symptomatic) hypotension | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild (asymptomatic) systolic hypotension | Cardiac disorders | Systematic Assessment |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Olakunle I. Makinde | Federal Medical Centre, Yenagoa | 08032136315 | olakunleife@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Oct 12, 2020 | Aug 27, 2022 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D008278 | Magnesium Sulfate |
| D010423 | Pentazocine |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
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|
|
| Pentazocine | Drug | 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. |
|
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 |
| 24 hours post-operative |
| Mean Dose of Pentazocine Used | Mean dose of Pentazocine used in each arm of the study | 24 hours post-operative |
| 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. | First 24 hours post-operative |
| 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 | At first and fifth minutes after birth |
| Background |
| Dinis J, Soto E, Pedroza C, Chauhan SP, Blackwell S, Sibai B. Nonopioid versus opioid analgesia after hospital discharge following cesarean delivery: a randomized equivalence trial. Am J Obstet Gynecol. 2020 May;222(5):488.e1-488.e8. doi: 10.1016/j.ajog.2019.12.001. Epub 2019 Dec 6. |
| 24772415 | Background | Kahraman F, Eroglu A. The effect of intravenous magnesium sulfate infusion on sensory spinal block and postoperative pain score in abdominal hysterectomy. Biomed Res Int. 2014;2014:236024. doi: 10.1155/2014/236024. Epub 2014 Mar 19. |
| 29333156 | Background | McKeown A, Seppi V, Hodgson R. Intravenous Magnesium Sulphate for Analgesia after Caesarean Section: A Systematic Review. Anesthesiol Res Pract. 2017;2017:9186374. doi: 10.1155/2017/9186374. Epub 2017 Dec 3. |
| 28077538 | Background | Shin HJ, Kim EY, Na HS, Kim TK, Kim MH, Do SH. Magnesium sulphate attenuates acute postoperative pain and increased pain intensity after surgical injury in staged bilateral total knee arthroplasty: a randomized, double-blinded, placebo-controlled trial. Br J Anaesth. 2016 Oct;117(4):497-503. doi: 10.1093/bja/aew227. Epub 2016 Oct 17. |
| 27853692 | Background | Kalani N, Sanie MS, Zabetian H, Radmehr M, Sahraei R, Kargar Jahromi H, Zare Marzouni H. Comparison of the Analgesic Effect of Paracetamol and Magnesium Sulfate during Surgeries. World J Plast Surg. 2016 Sep;5(3):280-286. |
| 23833845 | Background | Murphy JD, Paskaradevan J, Eisler LL, Ouanes JP, Tomas VA, Freck EA, Wu CL. Analgesic efficacy of continuous intravenous magnesium infusion as an adjuvant to morphine for postoperative analgesia: a systematic review and meta-analysis. Middle East J Anaesthesiol. 2013 Feb;22(1):11-20. |
| 23121612 | Background | Albrecht E, Kirkham KR, Liu SS, Brull R. Peri-operative intravenous administration of magnesium sulphate and postoperative pain: a meta-analysis. Anaesthesia. 2013 Jan;68(1):79-90. doi: 10.1111/j.1365-2044.2012.07335.x. Epub 2012 Nov 1. |
| 19933175 | Background | Hwang JY, Na HS, Jeon YT, Ro YJ, Kim CS, Do SH. I.V. infusion of magnesium sulphate during spinal anaesthesia improves postoperative analgesia. Br J Anaesth. 2010 Jan;104(1):89-93. doi: 10.1093/bja/aep334. |
| 15678729 | Background | Apan A, Buyukkocak U, Ozcan S, Sari E, Basar H. Postoperative magnesium sulphate infusion reduces analgesic requirements in spinal anaesthesia. Eur J Anaesthesiol. 2004 Oct;21(10):766-9. doi: 10.1017/s026502150400002x. |
| Background | Helmy N, Badawy AA, Hussein M, Reda H. Comparison of the preemptive analgesia of low dose ketamine versus magnesium sulphate on parturient undergoing caesarean section under general anaesthesia. Egypt. J. Anaesth. 2015;31(1):53-58. |
| 16615926 | Background | Paech MJ, Magann EF, Doherty DA, Verity LJ, Newnham JP. Does magnesium sulfate reduce the short- and long-term requirements for pain relief after caesarean delivery? A double-blind placebo-controlled trial. Am J Obstet Gynecol. 2006 Jun;194(6):1596-602; discussion 1602-3. doi: 10.1016/j.ajog.2006.01.009. Epub 2006 Apr 17. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Kilograms | Mean | Standard Deviation | Kilograms |
|
| Parity | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| 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) | Posted | Mean | Standard Deviation | score on a scale | 8 hours post-operative |
|
|
|
| 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) | Posted | Mean | Standard Deviation | score on a scale | 24 hours post-operative |
|
|
|
| Primary | Post-operative Pentazocine Use | Whether or not Pentazocine was used post-operatively | Posted | Count of Participants | Participants | 24 hours post-operative |
|
|
|
| Primary | Pentazocine Use as Rescue Analgesia | Whether or not pentazocine was used as rescue analgesia | Posted | Count of Participants | Participants | 24 hours post-operative |
|
|
|
| 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 | Posted | Count of Participants | Participants | 24 hours post-operative |
|
|
|
| Primary | Mean Dose of Pentazocine Used | Mean dose of Pentazocine used in each arm of the study | Posted | Mean | Standard Deviation | Milligrams | 24 hours post-operative |
|
|
|
| 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 | 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 | Posted | Count of Participants | Participants | Time of first administration of peri-operative analgesia to 2 hours postoperative |
|
|
|
| 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. | Posted | Count of Participants | Participants | First 24 hours post-operative |
|
|
|
| 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 | Posted | Count of Participants | Participants | At first and fifth minutes after birth |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 4 |
| 4 |
| EG001 | Magnesium Sulphate and Pentazocine | 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 | 0 | 46 | 1 | 46 | 19 | 46 |
| EG002 | Pentazocine Only | Participants in the pentazocine arm of the study who received a combination of post-operative intramuscular pentazocine, intravenous paracetamol and rectal diclofenac | 0 | 50 | 0 | 50 | 20 | 50 |
| Mild (asymptomatic) diastolic hypotension | Cardiac disorders | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | Systematic Assessment |
|
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| D013456 |
| Sulfur Acids |
| D013457 | Sulfur Compounds |
| D001575 | Benzomorphans |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| Four times (as rescue analgesia) |
|
| Three times (as rescue analgesia) |
|
| Two times (as rescue analgesia) |
|
| Once (as rescue analgesia) |
|
| Not used at all |
|
| Absent |
|
| Systolic hypotension |
|
|
| Severe (Symptomatic) systolic hypotension |
|
|
| Diastolic hypotension |
|
|
| Severe (Symptomatic) diastolic hypotension |
|
|
| Vomiting |
|
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| Lightheadedness |
|
|
| Presyncope |
|
|
| 7-10 |
|
| Apgar score at the 5th minute |
|