Tramadol for postoperative pain treatment in children

Alexander Schnabel; Sylvia U Reichl; Christine Meyer‐Frießem; Peter K Zahn; Esther Pogatzki‐Zahn

doi:10.1002/14651858.CD009574.pub2

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Figure 1

Study flow diagram.

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Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Analysis 1.1

Comparison 1 Tramadol versus placebo, Outcome 1 Number of patients requiring rescue analgesia (PACU).

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Analysis 1.2

Comparison 1 Tramadol versus placebo, Outcome 2 Number of patients requiring rescue analgesia (PACU) (Subgroup: Surgery).

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Analysis 1.3

Comparison 1 Tramadol versus placebo, Outcome 3 Number of patients requiring rescue analgesia (PACU) (Subgroup: Dose).

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Analysis 1.4

Comparison 1 Tramadol versus placebo, Outcome 4 Time to first rescue analgesic (min).

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Analysis 1.5

Comparison 1 Tramadol versus placebo, Outcome 5 Number of patients with PONV (PACU).

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Analysis 1.6

Comparison 1 Tramadol versus placebo, Outcome 6 Number of patients with PONV (24h postop).

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Analysis 1.7

Comparison 1 Tramadol versus placebo, Outcome 7 Number of patients with respiratory depression.

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Analysis 2.1

Comparison 2 Tramadol versus morphine, Outcome 1 Number of patients requiring rescue analgesia (PACU).

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Analysis 2.2

Comparison 2 Tramadol versus morphine, Outcome 2 Number of patients requiring rescue analgesia (24h postop).

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Analysis 2.3

Comparison 2 Tramadol versus morphine, Outcome 3 Number of patients with respiratory depression.

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Analysis 3.1

Comparison 3 Tramadol versus nalbuphine, Outcome 1 Number of patients requiring rescue analgesia (24h postop).

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Analysis 3.2

Comparison 3 Tramadol versus nalbuphine, Outcome 2 Number of patients with PONV (PACU).

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Analysis 3.3

Comparison 3 Tramadol versus nalbuphine, Outcome 3 Number of patients with respiratory depression.

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Analysis 3.4

Comparison 3 Tramadol versus nalbuphine, Outcome 4 Number of patients with bradycardia.

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Analysis 4.1

Comparison 4 Tramadol versus pethidine, Outcome 1 Number of patients requiring rescue analgesia (PACU).

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Analysis 4.2

Comparison 4 Tramadol versus pethidine, Outcome 2 Number of patients with moderate/severe pain (PACU).

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Analysis 4.3

Comparison 4 Tramadol versus pethidine, Outcome 3 Number of patients with PONV (PACU).

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Analysis 4.4

Comparison 4 Tramadol versus pethidine, Outcome 4 Number of patients with respiratory depression.

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Analysis 4.5

Comparison 4 Tramadol versus pethidine, Outcome 5 Number of patients with bradycardia.

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Summary of findings for the main comparison. Tramadol compared with placebo

Tramadol compared with placebo for postoperative pain in children
Patient or population: children undergoing surgery Settings: hospital Intervention: 1 to 3 mg/kg tramadol intravenously Comparison: placebo
Outcomes	Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)	Comments
Number of patients requiring rescue analgesia (PACU)	RR 0.40 (0.20 to 0.78)	289 (5)	⊕⊕⊝⊝ low	double‐downgraded due to unexplained heterogeneity and limitations in the study design (use of different pain scales and triggers for rescue analgesia)
Number of patients with moderate to severe pain (PACU)		44 (1)	⊕⊝⊝⊝ very low	triple‐downgraded, due to high risk of publication bias, limitations in the study design (use of non‐validated pain scale) and imprecision of results (wide CIs)
Number of patients with PONV (PACU)	RR 0.84 (0.28 to 2.52)	215 (3)	⊕⊕⊕⊝ moderate	downgraded due to imprecision of results (wide CIs)
Number of patients with PONV (24 hours postoperatively)	RR 0.78 (0.54 to 1.12)	150 (4)	⊕⊕⊕⊝ moderate	downgraded due to imprecision of results (wide CIs)
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
RR = relative risk CI = confidence interval PONV = postoperative nausea and vomiting PACU = postoperative care unit

Summary of findings for the main comparison. Tramadol compared with placebo

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Summary of findings 2. Tramadol compared with morphine

Tramadol compared with morphine for postoperative pain in children
Patient or population: children undergoing surgery Settings: hospital Intervention: 1 to 2 mg/kg tramadol intravenously Comparison: 0.1 mg/kg morphine intravenously
Outcomes	Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)	Comments
Number of patients requiring rescue analgesia (PACU)	RR 1.25 (0.83 to 1.89)	127 (3)	⊕⊕⊝⊝ low	double‐downgraded due to unexplained heterogeneity and limitations in the study design (use of different pain scales and triggers for rescue analgesia)
Number of patients with moderate to severe pain (PACU)				no data available
Number of patients requiring rescue analgesia (24 hours postoperatively)	RR 1.62 (0.65 to 4.04)	151 (3)	⊕⊕⊝⊝ low	double‐downgraded due to unexplained heterogeneity and limitations in the study design (use of different pain scales and triggers for rescue analgesia)
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
RR = relative risk CI = confidence interval PONV = postoperative nausea and vomiting PACU = postoperative care unit

Summary of findings 2. Tramadol compared with morphine

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Summary of findings 3. Tramadol compared with nalbuphine

Tramadol compared with nalbuphine for postoperative pain in children
Patient or population: children undergoing surgery Settings: hospital Intervention: 0.75 to 3 mg/kg tramadol intravenously or intramuscularly Comparison: 0.1 to 0.3 mg/kg nalbuphine intravenously or intramuscularly
Outcomes	Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)	Comments
Number of patients requiring rescue analgesia (24 hours postoperatively)	RR 0.63 (0.16 to 2.45)	110 (2)	⊕⊝⊝⊝ very low	triple‐downgraded due to unexplained heterogeneity, limitations in the study design (use of different pain scales and triggers for rescue analgesia) and imprecision of results (wide CIs)
Number of patients with moderate to severe pain (PACU)		50 (1)	⊕⊝⊝⊝ very low	triple‐downgraded, due to high risk of publication bias, limitations in the study design (use of non‐validated pain scale) and imprecision of results (wide CIs)
Number of patients with PONV (PACU)	RR 1.00 (0.50 to 2.01)	137 (2)	⊕⊕⊝⊝ low	double‐downgraded due to unexplained heterogeneity and imprecision of results (wide CIs)
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
RR = relative risk CI = confidence interval PONV = postoperative nausea and vomiting PACU = postoperative care unit

Summary of findings 3. Tramadol compared with nalbuphine

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Summary of findings 4. Tramadol compared with pethidine

Tramadol compared with pethidine for postoperative pain in children
Patient or population: children undergoing surgery Settings: hospital Intervention: 1 to 3 mg/kg tramadol intravenously, per mouth or intramuscularly Comparison: 1 to 1.5 mg/kg pethidine intravenously, per mouth or intramuscularly
Outcomes	Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)	Comments
Number of patients requiring rescue analgesia (PACU)	RR 0.93 (0.43 to 2.02)	120 (2)	⊕⊝⊝⊝ very low	triple‐downgraded due to unexplained heterogeneity, limitations in the study design (use of different pain scales and triggers for rescue analgesia) and imprecision of results (wide CIs)
Number of patients with moderate to severe pain (PACU)	RR 0.64 (0.36 to 1.16)	94 (2)	⊕⊕⊝⊝ low	double‐downgraded due to unexplained heterogeneity and limitations in the study design (use of different pain scales and triggers for rescue analgesia)
Number of patients with PONV (PACU)	RR 0.75 (0.28 to 2.02)	156 (3)	⊕⊕⊝⊝ low	double‐downgraded due to unexplained heterogeneity and imprecision of results (wide CIs)
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
RR = relative risk CI = confidence interval PONV = postoperative nausea and vomiting PACU = postoperative care unit

Summary of findings 4. Tramadol compared with pethidine

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Summary of findings 5. Tramadol compared with fentanyl

Tramadol compared with fentanyl for postoperative pain in children
Patient or population: children undergoing surgery Settings: hospital Intervention: 0.5 mg/kg bolus followed by 150 μg/kg/h tramadol intravenously Comparison: 2 µg/kg/h fentanyl intravenously
Outcomes	Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)	Comments
Number of patients requiring rescue analgesia (24 hours postoperatively)		28 (1)	⊕⊝⊝⊝ very low	triple‐downgraded, due to high risk of publication bias, limitations in the study design and imprecision of results (wide CIs)
Number of patients with moderate to severe pain (PACU)				no data available
Number of patients with PONV (24 hours postoperatively)		28 (1)	⊕⊝⊝⊝ very low	triple‐downgraded, due to high risk of publication bias, limitations in the study design and imprecision of results (wide CIs)
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
RR = relative risk CI = confidence interval PONV = postoperative nausea and vomiting PACU = postoperative care unit

Summary of findings 5. Tramadol compared with fentanyl

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Comparison 1. Tramadol versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Number of patients requiring rescue analgesia (PACU) Show forest plot	5	289	Risk Ratio (M‐H, Random, 95% CI)	0.40 [0.20, 0.78]

2 Number of patients requiring rescue analgesia (PACU) (Subgroup: Surgery) Show forest plot	5	289	Risk Ratio (M‐H, Fixed, 95% CI)	0.42 [0.33, 0.54]

2.1 Abdominal surgery	1	44	Risk Ratio (M‐H, Fixed, 95% CI)	0.6 [0.34, 1.07]
2.2 ENT Surgery	4	245	Risk Ratio (M‐H, Fixed, 95% CI)	0.39 [0.30, 0.52]
3 Number of patients requiring rescue analgesia (PACU) (Subgroup: Dose) Show forest plot	5	289	Risk Ratio (M‐H, Fixed, 95% CI)	0.42 [0.33, 0.54]

3.1 Tramadol 1mg iv.	2	90	Risk Ratio (M‐H, Fixed, 95% CI)	0.07 [0.02, 0.21]
3.2 Tramadol 2mg iv.	2	124	Risk Ratio (M‐H, Fixed, 95% CI)	0.63 [0.48, 0.83]
3.3 Tramadol 3mg iv.	1	75	Risk Ratio (M‐H, Fixed, 95% CI)	0.62 [0.38, 1.02]
4 Time to first rescue analgesic (min) Show forest plot	3	154	Mean Difference (IV, Random, 95% CI)	44.66 [‐24.26, 113.58]

5 Number of patients with PONV (PACU) Show forest plot	3	215	Risk Ratio (M‐H, Fixed, 95% CI)	0.84 [0.28, 2.52]

6 Number of patients with PONV (24h postop) Show forest plot	4	150	Risk Ratio (M‐H, Fixed, 95% CI)	0.78 [0.54, 1.12]

7 Number of patients with respiratory depression Show forest plot	3	165	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 1. Tramadol versus placebo

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Comparison 2. Tramadol versus morphine

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Number of patients requiring rescue analgesia (PACU) Show forest plot	3	127	Risk Ratio (M‐H, Fixed, 95% CI)	1.25 [0.83, 1.89]

2 Number of patients requiring rescue analgesia (24h postop) Show forest plot	3	151	Risk Ratio (M‐H, Fixed, 95% CI)	1.62 [0.65, 4.04]

3 Number of patients with respiratory depression Show forest plot	4	190	Risk Ratio (M‐H, Fixed, 95% CI)	0.18 [0.01, 3.51]

Comparison 2. Tramadol versus morphine

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Comparison 3. Tramadol versus nalbuphine

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Number of patients requiring rescue analgesia (24h postop) Show forest plot	2	110	Risk Ratio (M‐H, Random, 95% CI)	0.63 [0.16, 2.45]

2 Number of patients with PONV (PACU) Show forest plot	2	137	Risk Ratio (M‐H, Fixed, 95% CI)	1.00 [0.50, 2.01]

3 Number of patients with respiratory depression Show forest plot	2	74	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

4 Number of patients with bradycardia Show forest plot	2	74	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 3. Tramadol versus nalbuphine

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Comparison 4. Tramadol versus pethidine

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Number of patients requiring rescue analgesia (PACU) Show forest plot	2	120	Risk Ratio (M‐H, Random, 95% CI)	0.93 [0.43, 2.02]

2 Number of patients with moderate/severe pain (PACU) Show forest plot	2	94	Risk Ratio (M‐H, Fixed, 95% CI)	0.64 [0.36, 1.16]

3 Number of patients with PONV (PACU) Show forest plot	3	156	Risk Ratio (M‐H, Fixed, 95% CI)	0.75 [0.28, 2.02]

4 Number of patients with respiratory depression Show forest plot	3	236	Risk Ratio (M‐H, Fixed, 95% CI)	0.2 [0.01, 4.03]

5 Number of patients with bradycardia Show forest plot	2	160	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 4. Tramadol versus pethidine

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